Cardiovascular research

As one of the largest cardiovascular (heart and blood vessels) specialist centres in the UK, we carry out lots of different research. This includes new surgical treatments, and better ways to manage disturbances in heart rhythm (known as arrhythmias).

Find out how imaging is transforming care for cardiac patients

At Guy's and St Thomas’, cardiologists are working to improve the way they use imaging to diagnose and treat patients with cardiac disorders.

  • How imaging is transforming care for cardiac patients – video transcript

    Prof Mark O’Neill: One of the challenges facing us today is applying a new paradigm to the management of our patients with cardiovascular disease. With our diagnostic capabilities we can personalise our investigation of a patient and subsequently personalise the treatment of that patient.

    Prof Reza Razavi: By not only looking at the patient's history and their ECGs but actually by looking at the substrate at what's going on inside the heart we can have a some idea of which patients are likely to respond and which might not.

    Prof Aldo Rinaldi: We can use data that's been derived from magnetic resonance imaging or even CT scanning imaging now and this can give us an idea of the patient's anatomy by using computer modelling we can test whether a patient will respond to therapy so we're moving much more towards the sort of precision or targeted approach in individual patients try to improve response. 

    Prof Mark O’Neill: Guy's and St Thomas' is one of the largest teaching hospitals, university hospitals, in the United Kingdom based in the centre of London there has in fact been a St Thomas' Hospital based on the Southbank of the Thames since the 12th century. The clinical and intellectual atmosphere here is unique together with my colleagues in bioengineering and advanced cardiovascular imaging including MR physics we have the ability to answer very quickly questions which we ask. All under one roof. We're seeking to expand the boundaries of how diagnostic imaging can inform therapeutic intervention in patients with heart rhythm disturbances, to understand why a particular patient on a particular day suffers a rhythm disturbance which could potentially be fatal. In the United Kingdom at least 1.5 to 2 percent of our population suffers with atrial fibrillation therefore it's very important for us to find better ways to manage this condition in a more cost-effective way. The current interventions we use seek to ablate or destroy in a controlled way clearly defined cardiac tissue. Advanced cardiac imaging allows us to assess atrial structure. It's important for us to understand which parts of the atrium are the sites that we should target and also how safely can we target them. Sitting here within the XMR environment, we have the ability to take a patient on the morning of their procedure, perform a scan to assess their atrial structure and function, and then to tailor our procedure according to that individual patient's anatomy and depending on where we see sites with scar or abnormal tissue or sites with thick or thin atrial tissue.

    Prof Aldo Rinaldi: Cardiac resynchronisation therapy is an extremely powerful treatment. But approximately a third of patients don't respond to this treatment. By looking for areas of scar, by looking for areas of late electrical or mechanical activation and by using that data and taking it into the catheter lab to actually guide the procedure at the time, we hope to be able to then make a bespoke treatment for the patient to guide the lead to the optimal position in that patient's heart to improve the response to therapy. We were also able to develop in conjunction with our biomedical engineers here, biophysical models derived from MRI and electrical input. We can actually test in silicone what the response to a patient's treatment will be before we actually give it to the patient. There are several studies and programmes we're undertaking in conjunction with other centres in the UK and Europe actually to validate these models. Also we want to make the models more sophisticated and require less invasive data. We want them to be quicker as well so we hope to be able to now create this in hours to minutes in the future.

    Prof Reza Razavi: When we are looking at patients with ventricular tachycardia, cardiac MR allows us to image the shape and size of the ventricle in its function but particularly it allows us to image the scar and the areas around the scar, the border zone, or the grey zone, but getting that information into the cardiac catheterisation laboratory is difficult. That is why we're pursuing doing these procedures inside the MR scanner where we can both observe the substrate accurately but also accurately to target it by tracking our device to do the ablation, the catheter into the right part of the substrate. We can ablate arrhythmias in patients inside an MR scanner for atrial flutter but doing this for ventricular tachycardia is much harder. We have developed the technologies working with Siemens Healthcare and Imricor to be able to do this in an animal model and a next step over the coming year or two for us is to translate that into studies in patients.

    Prof Mark O’Neill: Almost every patient we see is interested in understanding better why they have suffered the problem they have suffered. Therefore every patient who comes into hospital contact with a doctor or a nurse is offered the opportunity, if appropriate, to participate in a research study.

    Dr Ronak Rajani: The UK's National Health Service indicates that all patients should have access to clinical research should they wish to be involved in research. We do screening of patients as they attend their clinics and patients are identified if they have specific pathological conditions or clinical disease states and if these conditions match up to current research studies they are approached for inclusion into these research studies. The transition of clinical data acquisition will ultimately be dependent on the publication and dissemination of our research findings but we are already starting to see that patients are benefitting from some of the work that's being conducted on our site.

    Prof Mark O’Neill: With the support of the infrastructure provided by the NHS, King's College London and our in-house services in bioengineering medical physics, cardiovascular imaging and interventional cardiac electrophysiology we hope that our work using imaging technology to assess arrhythmia substrate in patients will lead to earlier identification of patients for whom intervention is appropriate and better interventions in those patients.

 

Current research studies

We are currently looking for volunteers to take part in the following studies. Find out more about each study and see if you might be eligible to take part and help us with our research.

  • SELECT

    Have you ever had a heart attack or stroke? Do you have poor circulation?

    Research has shown that treatment with semaglutide may reduce the risk of stroke and heart attack in people with type 2 diabetes. 

    In a study called SELECT, we will check to see if semaglutide reduces the risk of cardiovascular events such as heart attack and stroke in people with overweight or obesity.

    You may qualify to participate in the SELECT study if:

    • you have had a brain attack (stroke), or heart attack (myocardialinfarction), or have poor circulation (peripheral arterial disease)
    • you are 45 years old or older
    • you are living with overweight or obesity
    • you are able to attend regular clinic visits and receive phone calls over a period of 3-5 years.

    The benefits of being involved in the SELECT study are:

    • study-related care, including regular health check-ups
    • general talks with a dedicated team of doctors and nurses
    • guidance on healthy lifestyle choices.

    This study is currently recruiting.

    For more information, please contact Federico Borchini, clinical research nurse, on Federico.Borchini@gstt.nhs.uk.

    Trial ID: EX9536-4388, version 1.0, date 18-MAY-2018, Global Master

  • SYNTAX

    The SYNTAX trial was the first large-scale randomized trial that randomly assigned patients with coronary artery
    disease (CAD) to undergo Coronary Artery Bypass Grafting (CABG) versus Percutaneous Coronary Intervention (PCI)
    with drug-eluting stents. It is currently considered to be the most important trial of CABG versus PCI. Follow-up to five
    years demonstrated that the difference in mortality between the two groups continued to diverge, with significantly lower
    rates of cardiac death, heart attack and repeat revascularization in favour of CABG.

    Unfortunately, the SYNTAX trial completed at the five year follow-up. Therefore, numerous questions on the debate of whether CABG or PCI provide better outcomes remain
    unanswered. Therefore a new study called the SYNTAXES has been approved to assess all cause death at ten years.

    All eight participating UK hospitals will provide NHS details on all SYNTAXES patients in order to collect survival status from the
    NHS database (dead or alive, exact date of death).

    If you were previously enrolled into the SYNTAX trial and would prefer not to have this information about you included in the ten year follow-up, please contact Professor Simon Redwood on 020 7188 9435.

Previous studies

Read about past studies. Please note we are no longer recruiting volunteers for these trials.

Valvular heart disease

  • Novel percutaneous techniques for percutaneous treatment of mitral regurgitation

    Title: Novel percutaneous techniques for percutaneous treatment of mitral regurgitation in subjects unsuitable for conventional cardiac surgery.

    Guy's and St Thomas’ is one of the world’s leading institutions for the delivery of percutaneous valve interventions and undertook the first human transcatheter mitral valve implantations in 2014. The team are now leading several international collaborative studies exploring innovative techniques for percutaneous mitral annular placation and mitral valve implantation using both existing devices designed for use in the aortic position (Edwards S3 Boston Lotus) or novel device designs (MvRx MAVERIC and Medtronic Twelve).

    Investigators: Simon Redwood, Bernard Prendergast, Ronak Rajani, Jane Hancock, Vinnie Bapat. 

  • Collaborations on transcatheter technologies for patients with severe aortic stenosis

    Title: International collaborations on novel transcatheter technologies for patients with severe aortic stenosis (the Respond and SAVI Registries).

    Post-market surveillance registries for the SYMETIS ACURATE neo Aortic Bioprosthesis, the ACURATE TF Transfemoral Delivery System and the Boston Scientific Lotus transcatheter heart valve for patients with severe aortic stenosis who are at high risk for conventional open AVR. The objective of the studies is to collect real world clinical, safety and device performance outcomes (1000 patients per study). All patients will be followed up for five years.

    Investigators: Bernard Prendergast, Jane Hancock, Karen Wilson, Chris Young, Vinnie Bapat, Simon Redwood.

  • Service evaluation for infective endocarditis

    Title: Service evaluation for infective endocarditis.

    This department service evaluation is to establish the relapse rate of infective endocarditis in patients who have been treated surgically at the cardiovascular centre over a 10 year period. In the past, the practice has been to use abbreviated post-operative antibiotic courses. This service evaluation may provide evidence that the duration of recommended antibiotic courses as stated in the current guidelines may be excessive.

    In order to complete the service evaluation, patients who fall under the criteria have been identified and patient identifiers, including NHS number, gender, postcode and date of birth are disclosed to the Health and Social Care Information Centre (HSCIC) so that the HSCIC can link those identifiers to the Hospital Episode Database (HES) and provide a file back to the centre which contains the identifying information together with the hospital episode information from databases held by the HSCIC. It may be necessary for us to contact the consultant responsible for the care episode to discuss and clarify diagnosis should, and only if, a HES suggest a possible episode of infective endocarditis. The data received then has the identifiers removed so that the analysis can be conducted on a pseudonymised dataset which protects patient confidentiality.

    Any patients who do not wish for their data to be used in this way can easily opt out of the analysis by contacting the centre on 020 7188 1047 (Professor John Chambers) or by emailing the centre on gst-tr.cardiology@nhs.net.

  • Comparison of the Toronto stentless and
    Perimount stented biological aortic replacement valve

    Title: A randomised long-term comparison of the Toronto stentless and Perimount stented biological aortic replacement valve.

    Stentless valves were introduced with the expectation of better haemodynamic function, and durability with lower event rates.  This is a prospective randomised trial begun in 1994 to compare long-term clinical events and failure rates with two different classes of replacement aortic valve. Early results showed no difference in haemodynamic function. 

    Investigators: Denise Parkin, Christopher Blauth, John Chambers.

  • Comparison of the Mosaic porcine and Perimount pericardial stented biological replacement aortic valves

    Title: A comparison of failure rates in the Mosaic porcine and Perimount pericardial stented biological replacement aortic valves.

    Anecdotal evidence suggests that the Mosaic valve has higher than expected rates of early structural deterioration.  This is a case-matched comparison with an industry-standard.

    Investigators: Denise Parkin, Jess Webb, John Chambers.

  • Methods of improving the community detection of heart valve disease

    Title: Methods of improving the community detection of heart valve disease

    Heart valve disease is often undetected and the key lies in the community. This is a programme investigating: the effect of devolved sonographer-led services; quick-scans as a screening mechanism; and intelligent software.   

    Chief UK investigator: CA Rinaldi.

  • Infective endocarditis after valve replacement

    Title: Infective endocarditis after valve replacement: data linkage studies to determine outcomes after surgical and transcatheter valve implantation and the impact of NICE 2008 guidelines on prosthetic valve endocarditis.

    This retrospective observational cohort study will link “big data” from NICOR (National Audit of Adult Cardiac Surgery and TAVI registry) and Hospital Episode Statistics (HES) to determine whether prosthetic valve endocarditis is more common after TAVI or SAVR and more frequent since radical changes in antibiotic prophylaxis guidelines instigated by NICE in 2008. Both questions are of major international relevance and can only be answered using unique NHS data.

    Investigators: Simon Redwood, Tom Cahill, Bernard Prendergast.

  • The HeArt ValvE Clinic International Database
    (The HAVEC registry)

    Title: The HeArt ValvE Clinic International Database (The HAVEC registry).

    This is an international multicentre observational investigation of the safety of conservative management in patients with severe aortic stenosis or degenerative mitral regurgitation. 

    Investigators: John Chambers, Magdalena Garbi, Raphael Rosenhek, Philippe Pibarot, Catherine Otto, Luc Piérard Patrizio Lancellotti.

  • Prevention of aortic stenosis pilot trial

    Title: Prevention of aortic stenosis pilot trial.

    This is a two-centre feasibility study of the use of sevelamer to lower phosphate levels in patients with early aortic stenosis.

    Investigators: David Wald, John Chambers.

  • Medtronic PERIcardial SurGical AOrtic Valve ReplacemeNt Pivotal Trial (PERIGON)

    Title: Medtronic PERIcardial SurGical AOrtic Valve ReplacemeNt Pivotal Trial (PERIGON).

    This study includes patients requiring a surgical aortic valve replacement. The purpose of the study is to evaluate the safety and effectiveness of a new bovine pericardial stented aortic bioprosthesis from Medtronic. The collected data will be used to support regulatory applications in seeking market approval for the valve in Europe (CE Mark), the United States, Canada and other geographies.

    Investigators: Vinayat Bapat, Francesco Pirone.

  

Coronary disease

  • Fractional Flow Reserve Versus Angiography for Multivessel Evaluation 3 Trial (FAME 3)

    Title: Fractional Flow Reserve Versus Angiography for Multivessel Evaluation 3 Trial (FAME 3).

    The FAME 3 trial is a multicentre, international, randomised, controlled non-inferiority trial, looking at the treatment of multivessel coronary artery disease. The study is a comparison of Fractional Flow Reserve-Guided (FFR) Percutaneous Coronary Intervention (PCI) and Coronary Artery Bypass Graft (CABG) Surgery in patients with multivessel coronary artery disease.

    Investigators: Simon Redwood, Chris Young.

  • Effects of Remote Ischaemic Conditioning

    Title: Effects of Remote Ischaemic Conditioning on clinical outcomes in ST segment elevation myocardial infarction (MI) patients undergoing Primary Percutaneous Coronary Intervention (ERIC PPCI).

    In patients presenting with an ST-elevation MI (STEMI), early myocardial reperfusion using primary percutaneous coronary intervention (PPCI) is the most effective therapeutic intervention for limiting MI size, a major determinant of prognosis post-PPCI. However, despite PPCI, the morbidity and mortality of STEMI patients remain significant, paving the way for novel therapeutic strategies for protecting the heart against acute ischaemia-reperfusion injury (IRI). In this respect, remote ischaemic conditioning (RIC) represents a non-invasive and low cost therapeutic strategy for further reducing MI size, preventing the onset of heart failure, and improving clinical outcomes in PPCI patients.

    Investigators: Simon Redwood, Divaka Perera, James Coutts, Brian Clapp, Bernard Prendergast, Antonis Pavlidis.

  • REVascularisation for Ischaemic VEntricular Dysfunction (REVIVED-BCIS 2)

    Title: REVascularisation for Ischaemic VEntricular Dysfunction (REVIVED-BCIS 2).

    This study is looking at patients with ischaemic cardiomyopathy. Previous studies have demonstrated that those with viable myocardium have a strong survival advantage following revascularisation compared to medical therapy alone. This multicentre prospective randomised open controlled trial aims to evaluate the efficacy and safety of percutaneous coronary intervention (PCI) combined with optimal medical therapy (OMT) compared to OMT alone for ischaemic cardiomyopathy and viable myocardium.

    Investigators: Divaka Perera, Simon Redwood, Gerry Carr-White. 

  

Structural intervention

  • Optimal antithrombotic therapy after transcatheter aortic valve implantation (TAVI) – the GALILEO study

    Title: Optimal antithrombotic therapy after transcatheter aortic valve implantation (TAVI) – the GALILEO study.

    Stroke and other thromboembolic syndromes are feared complications of TAVI and the optimal regime of post-procedural antithrombotic therapy is unknown. In this large international multicentre randomised controlled trial, investigators at St Thomas’ are working with collaborators around the world to explore the role of the direct Factor Xa inhibitor, rivaroxaban, as an anticoagulation-based treatment strategy to reduce thromboembolic complications following successful TAVI.

    Investigators: Simon Redwood, Jane Hancock, Karen Wilson, Bernard Prendergast.

  • Comparing transcatheter aortic valve implantation (TAVI) and conventional aortic valve replacement

    Title: A randomised controlled trial comparing transcatheter aortic valve implantation (TAVI) and conventional aortic valve replacement in intermediate risk subjects (UK TAVI).

    Although TAVI is an established treatment option for inoperable subjects with symptomatic severe aortic stenosis and an alternative to open heart surgery in high risk subjects, its role in intermediate and low risk subjects is unclear. The St Thomas’ TAVI team is playing a leading role in this UK-wide randomised trial supported by the UK Health Technology Authority which will guide international practice in this controversial area.

    Investigators: Simon Redwood, Jane Hancock, Chris Young, Bernard Prendergast.

  • Investigation of the haemodynamic and
    physiological principles of patients with aortic stenosis

    Title: Investigations of the haemodynamic and physiological principles underlying paradoxical low flow-low gradient aortic stenosis in subjects undergoing transcatheter aortic valve implantation (TAVI).

    TAVI is a transformative treatment for aortic stenosis (AS).  However, there is a subgroup of patients who are unable to generate high velocities of blood flow across their narrowed aortic valves (so called low flow-low gradient AS) in whom the benefit of intervention is diminished. Using detailed invasive protocols established at St Thomas’ Hospital to examine the interaction of coronary flow and left ventricular pressure-volume relationships, we will assess the potential contribution of microvascular ischaemia to this condition and, by detailed characterisation of the low-flow aortic stenosis phenomenon, hope to identify early features of left ventricular decompensation which will allow optimal timing of intervention and guide future research into alternative therapeutic strategies.

    Investigators: Bernard Prendergast, Hannah McConkey, Simon Redwood.

  • Optimal treatment of coronary artery disease in patients with aortic stenosis undergoing TAVI (The ACTIVATION Trial)

    Title: Optimal treatment of coronary artery disease in patients with aortic stenosis undergoing TAVI (The ACTIVATION Trial).

    Coronary artery disease is common in patients with aortic stenosis but its clinical importance is unclear, particularly in the elderly cohort who present for TAVI. This multicentre randomised controlled trial (led by St Thomas’) will compare strategies of conservative management versus stenting in this high risk patient group.

    Investigators: Bernard Prendergast, Jane Hancock, Simon Redwood.

  • AMPLATZER Amulet Observational Post-Market
    Study

    Title: AMPLATZER Amulet Observational Post-Market Study.

    St Thomas’ Hospital are taking part in this prospective, multicentre, observational, non-randomised study looking at the use if the AMPLATZER Amulet Appendage Left Atrial Appendage Occluder. The Amulet device is a transcatheter, self-expanding nitinol device intended for use in preventing thrombus embolization from the LAA in patients with persistent or permanent Atrial Fibrillation (AF). The purpose of the Amulet observational post-market study is to compile real world outcome data on the use of the CE marked Amulet device in NVAF subjects.

    Investigators: Brian Clapp, Jas Gill, Stam Kapetanakis.

  

Cardiac resynchronisation therapy

  • RADI-CRT: Pressure Wire Guided Cardiac Resynchronisation Therapy

    Title: RADI-CRT: Pressure Wire Guided Cardiac Resynchronisation Therapy.

    An international clinical trial looking at hemodynamic guided CRT recruiting 280 patients in the UK & Italy. (ClinicalTrials.gov Identifier: NCT01464502). This study which is finishing recruitment and will be the largest multi-centre study of haemodynamic guidance for CRT and will inform CRT guidance.

    Chief investigator: CA Rinaldi.

  • ELECTRA European Lead extraction Controlled Registry on the practice of lead extraction

    Title: ELECTRA European Lead extraction Controlled Registry on the practice of lead extraction.

    This is the largest lead extraction study in over 3000 patients in Europe and will provide information on the practice of lead extraction. Guy's and St Thomas' was the UK site for this study. The study has finished recruitment and is awaiting publication.

    UK chief investigators: CA Rinaldi.

  • Standard care versus triventricular pacing in heart failure (STRIVE HF)

    Title: Standard care versus triventricular pacing in heart failure (STRIVE HF).

    A multicentre randomised control trial comparing standard cardiac resynchronisation pacing with triventricular pacing, which will demonstrate the efficacy of this novel pacing strategy. Recruitment underway and will include 10 UK centres.

    Chief investigators: CA Rinaldi.

  • Pro MRI study

    Title: Pro MRI study.

    A multinational study in collaboration with Biotronik Corp looking at use of MRI compatible pacemakers, which recently completed recruitment of 100 patients in over 10 European sites. (ClinicalTrials.gov Identifier: NCT01460992).

    Chief UK investigator: CA Rinaldi.

  • iSPOT study

    Title: iSPOT study.

    An international study of multisite pacing in the UK, Belgium and Israel. (ClinicalTrials.gov Identifier: NCT01883141).

    Investigators: CA Rinaldi.

  • MOre REsponse on Cardiac Resynchronisation Therapy with MultiPoint Pacing (MORE-CRT MPP)

    Title: MOre REsponse on Cardiac Resynchronisation Therapy with MultiPoint Pacing (MORE-CRT MPP).

    This prospective, randomised, multicentre trial will assess the impact of the multipoint pacing feature at 12 months in the treatment of patients not responding to standard cardiac resynchronisation therapy after six months

    Investigators: Aldo Rinaldi, Jas Gill, Mike Cooklin, Matt Wright, Shoaib Hamid, Paresh Metha.

  • MultiPoint™ Pacing Mapping Study
    (MPP MAPPING)

    Title: MultiPoint™ Pacing Mapping Study (MPP MAPPING).

    This prospective, observational, acute feasibility study at four centres, with six-month follow-up, will characterise left ventricular acute hemodynamic and electrical responses during cardiac resynchronisation therapy with different MultiPoint™ pacing settings, and also assess the relationship between electrical activation patterns and hemodynamic measurements during these pacing settings.

    Investigators: Aldo Rinaldi.

  • Expanding MRI Access for Patients with New and Existing ICDs and CRT-Ds (ENABLE MRI)

    Title: Expanding MRI Access for Patients with New and Existing ICDs and CRT-Ds (ENABLE MRI).

    A prospective, non-randomised, confirmatory, global study conducted as a post market study in Europe, Israel and Asia Pacific aimed at collecting data to confirm the safety and effectiveness of the ImageReady™ MR Conditional Defibrillation System when used in the 1.5T MRI environment under the labelled Conditions of Use (Phase I). The study will also assess medically necessary MR scans according to the labelled Conditions of Use to provide real-world scanning data.

    Investigators: Aldo Rinaldi.

  • WiCS-LV post market surveillance registry

    Title: WiCS-LV post market surveillance registry (device registry for post market clinical follow-up of the WiCS-LV system under a process of controlled release onto the market).

    An observational, prospective, non-randomised registry. Standard of care data will be collected for five years. The WiCS-LV system is an implantable cardiac pacing system capable of delivering pacing energy to the heart without using a pacing lead. The system provides endocardially delivered left ventricular stimulation as an alternative to the standard epicardial coronary sinus pacing lead stimulation for cardiac resynchronisation therapy.

    Investigators: Aldo Rinaldi.

  

Cardiac imaging

  • The role of early CT coronary angiography in
    patients with acute coronary syndrome

    Title: The role of early CT coronary angiography in the evaluation, intervention and outcome of patients presenting to the emergency department with suspected or confirmed acute coronary syndrome. RAPID CTA trial.

    Coronary artery disease (CAD) occurs when narrowing develops in the blood vessels supplying the heart. If the blood vessels become blocked, the patient may develop a critical lack of blood and oxygen getting to the heart muscle or an acute coronary syndrome (ACS) and be at risk of a heart attack, heart failure and death. Computerised tomography coronary angiography (CTCA) involves using a CT scan to identify blockages in the coronary arteries. It is slightly less accurate at identifying obstruction than invasive coronary angiography but has much fewer risks. It could, therefore, be used to improve the investigation of medium-risk patients. Patients will be allocated to either receive CTCA as part of their assessment or receive standard assessment without this test. We will then follow up patients for one year to determine the rate of bad outcomes (such as heart attack or death), quality of life, patient satisfaction, the use of diagnostic tests or treatments, and health care costs.

    Investigators: Ronak Rajani, Rebecca Preston, Arjun Nair, Laura Hunter.

    Funder: NIHR.

  

Image modelling

  • Safety and efficacy of the Veniti Vici™
    venous stent system

    Title: Safety and efficacy of the Veniti Vici™ venous stent system (Veniti, Inc) when used to treat clinically significant chronic non-malignant obstruction of the Iliofemoral venous segment.

    Prospective, multicenter, single arm, non-randomized study. The objective of this study is to assess the safety and efficacy of the Veniti Vici™ venous stent system in achieving patency of the target venous lesion through 36 months in patients who present with clinically significant chronic non-malignant obstruction of the iliofemoral venous outflow tract.

    Investigators: Mr S Black.

  • Bypass vs Angioplasty in Severe Ischaemia of the Leg-2 trial: BASIL-2 trial

    Title: Bypass vs. Angioplasty in Severe Ischaemia of the Leg-2 trial: BASIL-2 trial.

    An individually randomised multicentre two-arm open trial of two alternative revascularisation strategies (VB first vs. BET first) for the management of Severe Limb Ischaemia due to infra-popliteal, with or without femoro-popliteal, disease. To determine which strategy represents the most clinically and cost-effective treatment.

    Investigators: Mr H Zayed.

  • Investigation into the pathophysiology of lower limb ischaemia and how to promote therapeutic revascularisation

    Title: An investigation into the pathophysiology of lower limb ischaemia and how to promote therapeutic revascularisation in the critically ischaemic limb.

    This programme of work concentrates on three areas:

    i) To identify the distribution of important cells (from blood and/or muscle biopsies) (e.g. angiogenic monocytes) in patients with CLI and controls and compare the functional properties (in vitro and in vivo). ii) to develop novel MRI imaging methods to accurately quantify and map out tissue perfusion in ischaemic limbs. iii) To quantify the haemodynamic significance of arterial stenosis/occlusion and the collateral circulation in the lower limb of patients undergoing planned intra-arterial angiography/angioplasty with measurements of flow/pressure in the artery.

    Investigators: Mr B Modarai, Mr A Patel, Dr Ludwinski.

  • Effective treatments for Thoracic Aortic
    Aneurysms (ETTAA Study): a prospective cohort study

    Title: Effective treatments for Thoracic Aortic Aneurysms (ETTAA Study): a prospective cohort study

    A prospective, multicentre, observational, cohort study. To follow patients with a chronic thoracic aortic aneurysm (CTAA) of the aortic arch or descending aorta 4cm or over. To quantify clinical outcomes in each treatment cohort (watchful waiting WW, best medical therapy BMT, endovascular stent grafting ESG and open surgical repair OSR) in terms of survival and quality of life. To identify patient-specific or aneurysm-specific features that might predict poor outcome in each treatment group by risk-modelling methods and to estimate the clinical- and cost-effectiveness of competing treatments to define optimal management strategies for patients in whom more than one treatment is considered appropriate.

    Investigators: Miss R Bell.

  • The ROAM-CLI study: retention of angiogenic
    CD16+ monocytes in critical limb ischaemia

    Title: The ROAM-CLI study: retention of angiogenic CD16+ monocytes in critical limb ischaemia.

    The overall aim of this study is to determine:

    (i) whether it is feasible to isolate CD16+ monocytes from the peripheral blood of patients with CLI;

    (ii) radiolabel and deliver these cells into the ischaemic limb; and

    (iii) track these cells after delivery, using nuclear medicine imaging techniques, to determine the proportion of retained cells over time.  

    To examine the tissue retention of autologous CD16+ monocytes isolated from peripheral blood and then injected into the ischaemic limb.

    Investigators: Mr Modarai, Mr A Patel.

  • Thrombosis and its resolution: mechanisms and imaging

    Title: Thrombosis and its resolution: mechanisms and imaging.

    To investigate whether MRI (alone or in conjunction with circulating biomarkers) can provide information relating thrombus structure to the susceptibility to lysis; or predict whether a thrombus is likely to resolve rapidly through natural processes.  

    The central aims of this programme of work are as follows:

    (i) To investigate if novel MRI imaging methods can accurately quantify and characterise thrombosis in humans;

    (ii) To investigate whether MRI has utility in stratifying patients who respond favourably to lysis;

    (iii) To determine whether there are circulating biomarkers that relate to the structure of thrombosis as assessed by MRI.

  • A study of the mechanisms that give rise to
    vascular disease

    Title: A study of the mechanisms that give rise to vascular disease.

    The study objective is to gain a better understanding of the mechanisms that give rise to and propagate arterial occlusion (plaque) or arterial dilatation (aneurysms) would facilitate the development of: therapies that prevent plaque or aneurysm development and progression; or biomarkers of disease progression. This may come from access to blood and samples of plaque or aneurysm wall (that are available and normally disposed of during surgery), from which we can analyse the cellular and molecular ‘fingerprints’ of these conditions.

    Chief investigator: Professor Smith, principal investigator: Mr Modarai.

  • Markers of the susceptibility to aneurysm
    formation and progression

    Title: Markers of the susceptibility to aneurysm formation and progression.

    The main study objectives are:

    1. To elucidate inherited gene variants that predispose to aneurysmal disease using innovative exome or whole genome sequencing.

    2. To search for biomarkers, in the plasma or serum of these subjects, that may be directly be measured to predict the presence or progression of aneurysmal disease or act as a putative imaging target that is informative of the likelihood of progression.

    Chief investigator: Professor Smith; principal investigator: Mr Modarai.

  • Human studies in cardiovascular valve failure

    Title: Human studies in cardiovascular valve failure.

    To understand the processes controlling valve development in humans and how errors in these processes can lead to human disease: Are cardiac/venous/lymphatic valves or vessels abnormal in patients with a specific known genetic mutation? Is a particular gene of interest expressed (made into a protein) in cardiac/venous/lymphatic valves? Are other molecules that affect gene function found in cardiac/venous/lymphatic valves or vessels? In patients with abnormal cardiac/venous/lymphatic valves, is there a genetic abnormality?

    Chief investigator: Professor Smith; principal investigator: Mr Modarai, Mr O Lyons.

  • The role of adipose-derived stromal cells in lower
    limb ischaemia. Can they promote therapeutic neovascularisation?

    Title: An investigation into the role of adipose-derived stromal cells in lower limb ischaemia and whether they can promote therapeutic neovascularisation in patients with critically ischaemic limbs.

    To identify novel, potent cell types (e.g. angiogenic adipose derived stem cells) as candidates for angiogenic cell therapy in patients with leg ischaemia. To compare the angiogenic potential of adipose derived stem cells (ASCs) isolated from the fat in the ischaemic leg with fat from the non-ischaemic leg, upper limb and abdomen.

    Investigators: Mr B Modarai. 

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