Partners
Clinical testing of this project, with its aspirations to go beyond ‘state-of-the-art’ medical understanding, needs unusually deep expertise in both the clinical and research aspects of a study. Required capabilities include cutting-edge molecular cardiovascular imaging and wide knowledge of the immunobiology of cardiovascular disease. Bringing such a team of exceptional people together means looking beyond a single centre or even country. Explore how RITA-MI 2 has assembled a consortium comprised of Europe’s ‘best of the best’.
Institut National de la Santé et de la Recherche Médicale
Inserm is a French public body dedicated to biomedical research and human health. Partnering with prestigious research institutions around the world, its goal is improving the health of all through the advance of knowledge, innovation, and public health research. RITA-MI 2 will be handled by a specialist group within Inserm, PARCC, a multi-disciplinary team of research clinicians and scientists focused on accelerating understanding of cardiovascular disease. Inserm will also act as overall coordinator of the entire project consortium
Ziad Mallat is a British Heart Foundation Professor of Cardiovascular Medicine, at the University of Cambridge. He also co-supervises a research group at Inserm, Paris, where he has also served as a scientific advisor to the General Director. On the editorial board of a number of leading cardiovascular journals. His research is particularly concerned with the role of the immuno-inflammatory response in cardiovascular diseases – notably, his lab was the first to identify immune pathways that tame the atherosclerotic process. More recently, his team identified unsuspected roles for B lymphocytes in atherosclerosis and post-ischemic injury.
Prof. Hafid Ait-Oufella Dr. Alain Tedgui WP1 (Lead) – ensure optimal management and coordination of projectResearch team
Involvement by work package
WP3 – help ensure project’s conduct conforms to good clinical practice
WP5 – characterise the immune response in study subjects
WP6 – disseminate results, set up communication activities, and help manage the intellectual property
WP7 (Lead) – ensure the project complies with ethics requirements
Assistance Publique – Hôpitaux de Paris
AP-HP is the largest university hospital centre in Europe, with 39 hospitals in and around Paris – and the European leader in clinical research. It is the largest employer in the Ile-de-France region, with over 100,000 staff. Three teams are involved with RITA-MI 2: Team A based at Hôpital Bichat, a 1500-bed university teaching hospital with a busy cardiology/cardiac surgery department with extensive experience in clinical trials for acute cardiac care. Team B is from Hôpital Européen Georges Pompidou (HEGP), a teaching hospital with 24 clinical departments and 795 beds, known for its expertise treating cardiovascular conditions. Team C is led by the Clinical Research Platform of East Paris, a collaboration of researchers dedicated to supporting physicians of AP-HP in university hospitals, based at Hôpital Saint Antoine, Sorbonne University.
Philippe-Gabriel Steg is Professor of Cardiology at Université Paris Diderot, visiting professor at Imperial College, London, and head of the Cardiology Department, Hôpital Bichat, Paris. He is also Vice President (in charge of research) of the board of the Assistance Publique-Hôpitaux de Paris and Director of the Clinical Research in Atherothrombosis Research Team within INSERM. He is a coordinator of the Département Hospitalo-Universitaire FIRE (Fibrosis, Inflammation and REmodeling), chair of the French Alliance for cardiovascular Clinical Trials (FACT), chair of the French National University Council (‘Conseil National des Universités’) for Cardiology, and also coordinator of the iVASC (InnoVations in Atherothrombosis SCience) RHU research consortium.
Prof. Steg has experience as a clinical researcher of coronary artery disease, diabetes and antithrombotics and is currently leading several large phase 3 clinical trials and international registries. He received the silver medal of the European Society of Cardiology in 2011, the Joseph A Vita Award from the American Heart Association in 2019, and the Grand Prix Claude Bernard de la Ville de Paris in 2019. He has authored over 1,700 articles in peer-reviewed international journals, and has in excess of 115,000 citations. A Thomson Reuters/Clarivate Analytics ‘highly cited researcher’ in clinical medicine for every year since 2014, he is also Senior Associate Editor for Circulation and a member of the editorial board for several leading cardiovascular journals.
Research team
Hélène Abergel
Involvement by work package
WP1 – help ensure optimal management and coordination of project
WP3 (Lead) – patient recruitment, consent & treatment
WP4 – assessment of heart function using cardiac magnetic resonance (CMR);
collect blood for later immunophenotyping and biomarker evaluation
WP6 – communicate results to international scientific meetings and general public,
and contribute to other dissemination activities
Nicolas Danchin is Professor of Cardiology at Université Paris Descartes and at Hôpital Européen Georges Pompidou, Paris. He has a special interest in coronary artery disease and its treatment, including both preventative and interventional cardiology. He is Honorary President of the French Society of Cardiology and a past Chair of the Scientific Committee of the French National Health Insurance body.
Previously Chair of the Working Group on Acute Cardiac Care of the ESC, the Experts’ Committee of the Acute Coronary Syndromes Euro Heart Survey and the Committee on Regulatory Affairs of the ESC, he was also a member of the Nominating Committee of the ESC from 2008 to 2010. Prof. Danchin is the lead researcher of all French nationwide AMI registries for 1995-2015 (FAST-MI), and has published over 600 papers in PubMed-indexed journals.
Involvement by work package
WP3 (Lead) – patient recruitment, consent & treatment
WP4 – assessment of heart function using cardiac magnetic resonance (CMR);
collect blood for later immunophenotyping and biomarker evaluation
WP6 – communicate results to international scientific meetings and general public,
and contribute to other dissemination activities
Tabassome Simon is Professor of Clinical Pharmacology in the Department of Pharmacology, AP-HP, Saint-Antoine Hospital, Sorbonne University in Paris. She is Director of the Clinical Research Platform of East Paris (URC-CRB) and former chair of the European Association of Clinical Pharmacology and Therapeutics (EACPT), with substantial experience of multicentre clinical trials and registries.
Prof. Simon was the recipient of the Medal of Paris Saint Antoine University Hospital in 1992, and between 1999 – 2010 has received awards from the French Society of Cardiology, the French Society of Pharmacology, and the French Society of Angiology. She also received the EACPT Scientific Award in 2011. Chairing the French Alliance for Cardiovascular Clinical Trials (FACT), her own research interests are in the field of coronary artery disease. Prof. Simon is co-chair of French Alliance for Cardiovascular Clinical Trials (FACT), and coordinates biobanking in the French nationwide AMI registries (FAST-MI). She has published more than 260 original articles in international peer-reviewed journals.
Research team
Dr. Laurence Berard
Marine Cachanado
Elodie Drouet
Sandra Paco
Alexandra Rousseau
Involvement by work package
WP1 – help ensure optimal management and coordination of project
WP2 (Lead) – manage all regulatory aspects of the clinical trial, taking charge of its
management, coordination and monitoring
WP3 (Lead) – ensure project’s conduct conforms to good clinical practice; data
management and analysis
WP6 – communicate results to international scientific meetings and general public,
and contribute to other dissemination activities
WP7 (Co-lead) – ensure the project complies with ethics requirements
AP-HP, as sponsor of the study, is responsible for the overall management of the trial.
The sponsor objectives:
- Implement the study design, following both protocol and current international standards and laws
- Ensure the rights and well-being of study participants are protected and that researchers comply with the approved protocols
- Bring together and train a study group of leading clinical centres for the conduct of a randomized phase 2 study
- Lead, perform, monitor and report on the clinical study
- Oversee pharmaceutical safety standards
- Manage the clinical database
The sponsor’s activities will be performed by the following:
- Clinical Research and Innovation Direction (CRID, or DRCI in French), part of AP-HP, oversees the CTA dossier preparation and the regulatory and ethical submissions. It also manages contractual matters as well as pharmaceutical safety standards
- Clinical Research Platform of East Paris (URC-CRB, CTU in English), part of AP-HP, is responsible for coordinating the various site set-ups and their monitoring, managing the trial in France, and is also in charge of the overall data-management and statistical analysis
- Contract Research Organization (CRO) will be externally subcontracted to support the clinical study. Its tasks include making national registrations and ethics submissions, local project management and monitoring, and overseeing national pharmaceutical safety standards
The AGEPS (Agence Générale des Equipements et Produits de Santé, General Agency for Equipments and Health Products) Clinical Trial department advises the DRCI Clinical Trial Sponsoring (Promotion) department, the Clinical Research Platform and Hospital Pharmacies on the trial pharmaceutical aspects management and organisation.
Sponsor team
Serge Bureau, DRCI
Sophie Courtial-Destembert, DRCI
Emmanuelle Liegey, DRCI
Elodie Perrot, AGEPS
Annick Tibi, AGEPS
Papworth Hospital NHS Foundation Trust
Papworth Hospital is the largest specialist cardiothoracic hospital in the UK and the country’s main heart and lung transplant centre. Over the last three years, Papworth has performed the highest number of heart surgery procedures in the UK while boasting the country’s lowest associated mortality rate. An onsite clinical trials unit makes research a core activity, with over 100 research studies currently recruiting – and over 40 of these sponsored by the unit itself.
Stephen Hoole is an interventional research lead, consultant cardiologist and a research champion, with half his professional hours dedicated to translational research. He has a doctorate in cardioprotection during percutaneous coronary intervention (PCI) and presently holds a national clinical excellence bronze award. Having published over 100 peer reviewed manuscripts, he is a senior research fellow at the University of Cambridge and an adviser to the Medicines and Healthcare Products Regulatory Agency (MHRA) interventional device programme, the National Institute for Health and Care Excellence (NICE) interventional procedures programme and to the NIHR Health Technology Assessment (HTA) programme. He is an Expert Adviser for the NICE Centre for Guidelines and has participated in guideline and position paper publications for the European Society of Cardiology (ESC), American College of Cardiology (ACC), American Heart Association (AHA) and NICE, and is currently appointed as a NICE clinical guideline chair.
Research team
Kim Giraud
Involvement by work package
WP3 – recruit, treat and follow up 36 patients
WP4 – perform CMR and FDG-PET/CT in 36 patients;
collect blood for later immunophenotyping and biomarker evaluation
WP6 – communicate results to international scientific meetings and general public,
and contribute to other dissemination activities
Klinikum rechts der Isar, Technische Universität München
Klinikum rechts der Isar is the university hospital of the Technical University Munich. Founded in 1834, it provides state-of-the-art medicine, research and innovation. Around 5,500 people work at the hospital, with 30 departments, 20 interdisciplinary centres and over 1,100 beds. The Intensive care unit and emergency department treat 150 – 200 STEMI patients a year, while the cardiology department has a strong tradition of myocardial infarction trials.
Karl-Ludwig Laugwitz qualified in medicine in Berlin before gaining a postdoctoral teaching qualification (Habilitation) from the TUM School of Medicine in 2002, and was appointed as a professor at Harvard Medical School in 2005. Since 2012 he has been Clinical Director of the Clinic and Polyclinic of Internal Medicine I (Cardiology, Angiology and Pneumology) at Klinikum rechts der Isar. He is a highly cited cardiologist with over 450 publications and 8 patents.
Research team
Sabrina Doering
Dagmar Reitberger
Prof. Wolfgang Weber
Involvement by work package
WP3 – recruit, treat and follow up 30 patients
WP4 – perform CMR and FDG-PET/CT in 30 patients;
collect blood for later immunophenotyping and biomarker evaluation
WP6 – communicate results to international scientific meetings and general public,
and contribute to other dissemination activities
Instituto Investigacion Sanitaria Fundación Jiménez Diaz
Fundación Jiménez Díaz university hospital in Spain is the flagship of a network of hospitals serving over 1 million people, with an interventional cardiology department that performs over 1000 PCI procedures a year. In addition to care activity, its research institute (Instituto Investigación Sanitaria) boasts an impressive record in clinical research. The institute has long-standing collaborations in place for developing research projects in both STEMI and myocardial ischemia/reperfusion. Fundación Jiménez Díaz Hospital has a strong tradition of collaboration with the Spanish National Center for Cardiovascular Research (CNIC), who are a connected third party on this project.
Borja Ibáñez (MD/PhD) combines his research activities as Director of Clinical Research at the National Center for Cardiovascular Research, Spain, with his duties as cardiologist at the university hospital, Fundación Jiménez Díaz. His research is mainly in the fields of myocardial infarction, heart failure and cancer therapy-induced cardiotoxicity. An advanced imaging user, he uses magnetic resonance imaging to better understand the pathophysiology of myocardial diseases and to evaluate the benefits of cardioprotective therapies.
He has acted as team lead on several multicentre clinical trials recruiting patients with myocardial infarction and heart failure – and has served as the chair of the 2017 ESC STEMI Clinical Practice Guidelines. Having published almost 300 articles in high profile journals, he is also active in peer review – and holds several patents, with some in the field of CMR.
Research team
Dr. Andrea Moreno Arciniegas
Dr. Felipe Navarro
Dr. Antonio Pinero
Dr. Sandra Gómez-Talavera
Dr. Paloma Avila-Barahona
Dr. Javier Sanchez-Gonzalez
Involvement by work package
WP4 (Lead) – perform CMR and FDG-PET/CT in 30 patients; lead assessment of heart function and vascular inflammation; collect blood for later immunophenotyping and biomarker evaluation; act as core lab for CMR; perform blind analysis of partners’ studies
WP6 – communicate results to international scientific meetings and general public,
and contribute to other dissemination activities
Uppsala University Hospital
Uppsala University Hospital is Sweden’s oldest and largest university hospital, caring for over 700,000 people every year. Its Clinical Research Centre (UCR) is a non-profit organisation undertaking clinical trials and maintaining national clinical registries. It also has a biobank/biochemistry research lab – and will be in charge of the RITA-MI 2 work. The UCR has around 140 staff, including the largest number of bio-statisticians and data managers in Swedish academia. The Centre provides full academic research services, drawing on the many specialisations and disciplines this entails.
Stefan James is Professor of Cardiology and Scientific Director of Uppsala Clinical Research Centre at Uppsala University, and also Senior Interventional Cardiologist at Uppsala University Hospital, Sweden. He is published in over 470 peer-reviewed cardiology journals, is an associate editor of Circulation, and an editorial board member for both the European Heart Journal and American Heart Journal.
Prof. Stefan has been team leader on numerous international cardiology trials and has pioneered the concept of registry-based, randomised clinical trials. He has served as chair of the Swedish Coronary and Angioplasty registry of SWEDEHEART and president of the Swedish Cardiac Society. He has received numerous research prizes and awards, and for several years has been named by Thomson Reuters as a ‘Highly Cited Researcher’, ranking him in the top 1% in clinical medicine.
Involvement by work package
WP3 – recruit 36 patients and carry out the protocol
WP4 – perfom CMR in 36 patients according to the protocol; collect blood for later
immunophenotyping and biomarker evaluation
WP6 – communicate results to international scientific meetings and general public,
and contribute to other dissemination activities
Soroka University Medical Center (part of Clalit Health Services)
Soroka University Medical Center, part of the Clalit group, is the third largest hospital in Israel, with 1,150 beds, and is a major teaching hospital. Its department of cardiology covers all aspects of modern heart treatment, with over 600 cardiothoracic surgeries every year – and is fully equipped with 3 cath labs, access to CT and MRI, a state-of-the-art electrophysiology lab and more. Clinical research at Soroka is at the forefront of national and international science, pushing the boundaries of technology and innovation.
Professor Doron Zahger is Director of the cardiology department at Soroka University Medical Center and president of the Israel Heart Society. He has served as team leader for various international studies, such as Odyssey Outcomes, Scored and Chiara MIA, as well as for many local trials.
Research team
Dr. Aryeh Shalev
Prof. Yigal Abramowitz
Involvement by work package
WP3 – recruit 36 patients and perform associated aspects of the study
WP4 – perform CMR in 36 patients according to study protocol; collect blood for later
immunophenotyping and biomarker evaluation
WP6 – communicate results to international scientific meetings and general public,
and contribute to other dissemination activities
Imperial College London
Imperial College stands at the forefront of education and research in science, engineering and medicine. The National Heart and Lung Institute (NHLI), a major department within its medical faculty, is a world leader in uncovering the mechanisms underlying chronic cardiovascular diseases. On RITA-MI 2, Imperial will collaborate closely with Royal Brompton Hospital, a dedicated cardiothoracic hospital in London.
Dr. Ranil de Silva is a Senior Lecturer in Clinical Cardiology at Imperial, and a consultant interventional cardiologist at the Royal Brompton Hospital, where he leads the Specialist Angina Service. He is also a lead clinical investigator at the National Institute for Health Research’s cardiovascular biomedical research unit.
Dr. de Silva’s clinical and research interests focus on the pathophysiology, investigation, risk stratification and treatment of complex stable coronary artery disease and acute coronary syndromes. He is published in several top-ranked journals, including New England Journal of Medicine, The Lancet, Nature, Journal of the American College of Cardiology, Circulation and European Heart Journal.
Involvement by work package
WP3 – recruit, treat and follow up 10 patients
WP4 – perform CMR imaging in 10 patients; cooperate with team in Madrid to assess
infarction, myocardial salvage and ventricular function in all patients included in the
study; collect blood for later immunophenotyping and biomarker evaluation
WP6 – communicate results to international scientific meetings and general public,
and contribute to other dissemination activities
Fakultní Nemocnice Královské Vinohrady
University Hospital Královské Vinohrady (FNKV), Prague, serves as a clinical teaching base for the third faculty of medicine of Charles University. It has evolved since its 1902 founding into a large, multi-department hospital and a cornerstone of Czech medical teaching and research. It provides a comprehensive array of cardiology services, including imaging and cardiac surgery. The hospital has previously collaborated on several international studies into acute coronary syndromes, as well as having its own established research programme.
FNKV has a strong tradition of collaboration with St. Anne’s University Hospital Brno (FNUSA), and more particularly with the International Clinical Research Center, which is a connected third party on this project.
Research team
Dr. Ota Hlinomaz
Involvement by work package
WP3 – recruit, treat and follow up 130 patients
WP4 – perform CMR imaging in 130 patients according to study protocol;
collect blood for later immunophenotyping and biomarker evaluation
WP6 – communicate results to international scientific meetings and general public,
and contribute to other dissemination activities
Maastricht University
Maastricht University, Netherlands, has built its reputation as a leading young university through an innovative education model that has diversity and a collaborative approach to research and education as its foundations. Within its faculties, the Cardiovascular Research Institute Maastricht (CARIM) is one of the largest cardiovascular research institutes in Europe, producing more than 500 scientific articles per year. CARIM will perform the RITA-MI 2 study in conjunction with the department of cardiology at Maastricht University Medical Centre+ (MUMC+).
Arnoud van ‘t Hof is full professor and Head of the Department of Interventional Cardiology, both at MUMC+ and Zuyderland Medical Center Heerlen, Netherlands. His long-standing cardiovascular research has focused on primary angioplasty and acute coronary syndrome, with him acting as team leader on a number of international, multi-centre trials. A board member of the Acute Cardiac Care association (ACCA) and on the editorial board of several cardiology journals, he has authored or co-authored over 400 publications in peer reviewed journals.
Research team
Dr. Ota Hlinomaz
Involvement by work package
WP3 – recruit, treat and follow up 100 patients
WP4 – perform CMR imaging in 100 patients according to study protocol; collect
blood for later immunophenotyping and biomarker evaluation
WP6 – communicate results to international scientific meetings and general public,
and contribute to other dissemination activities
Charité – Universitätsmedizin Berlin
Charité is one of the largest university hospitals in Europe, boasting over half Germany’s Nobel Prize winners in physiology and medicine – and its busy cardiology department is widely acknowledged as a world leader. A closely cooperating partner clinic, Berlin-Brandenburg Center for Regenerative Therapies (BCRT) will lead the RITA-MI 2 research. With a strong interdisciplinary research programme and over 250 staff, BCRT focuses on the development of new ways to stimulate immune and cardiovascular system regeneration through the use of bioactive and biological factors.
With over 220 PubMed articles, sitting on many national and international working groups and societies, and an enviable record conducting grant-funded national and international studies (often as team leader) he enjoys a favourable international reputation in his field.
Research team
Prof. Dr. Sebastian Kelle
Monika Willner
Involvement by work package
WP3 – recruit, treat and follow up 20 patients according to study protocols
WP4 – perform CMR imaging in 20 patients; collect blood for later
immunophenotyping and biomarker evaluation
WP6 – communicate results to international scientific meetings and general public,
and contribute to other dissemination activities
University of Cambridge
The University of Cambridge (UCAM) is one of the world’s oldest universities and leading academic centres. Its Cardiovascular Division is comprised of a collaborative group of cardiovascular investigators with expertise in basic, translational and clinical cardiovascular research and who employ genomics, epigenetics, high throughput sequencing, biomarker identification and validation, through to novel imaging, diagnostics and experimental medicine studies so as to improve patient outcomes. Cambridge Clinical Trials Unit (CCTU) is part of the Biomedical Research Centres (BRC) and is fully accredited by the NIHR. It currently has over 45 members of staff, and a portfolio of 30 active clinical trials, with a special focus on early phase, translational studies.
Research team
Prof. Ziad Mallat
Dr. Tian Zhao
Involvement by work package
WP3 – contribute to study conduct and patient recruitment
WP4 – collaborate on site with Papworth Hospital
WP5 – store and analyse biological samples for detailed immunophenotyping and
measuring of biomarkers
WP6 – communicate results to international scientific meetings and general public,
and contribute to other dissemination activities
Inserm Transfert
Founded in 2000, Inserm Transfert SA is the private subsidiary of the French National Institute of the Health and Medical Research (Inserm) and is dedicated to comprehensive technology transfer – from invention disclosure to industrial partnership. The collaborative research funding department of Inserm Transfert is ISO 9001 certified and has strong expertise in the financial and contractual rules of EU and national programmes, helping to smooth the way for European cooperation. The department is currently managing 29 collaborative projects in the field of life sciences and health funded by European (Horizon 2020) and national (Investissements d’Avenir) programmes. Having faced and solved many issues stemming from European cooperation in medical research, the team can anticipate and quickly address any challenges faced by collaborating teams.
A Project manager, Cécile Gozlan, holds a Master’s in European Studies and Project Management. She lived, studied and/or worked in the UK, Spain and the USA. An expert in the management of international and multidisciplinary collaborative research projects, she managed an INTERREG IVA French-British Marine Biology project at the University of Caen, France, and an FP7 Actions Marie Curie ITN project at the High-Field NMR Centre, CNRS, in Lyon, France. She joined Inserm Transfert’s Department of Collaborative Research Funding in 2020 and is currently managing 2 H2020 projects.
Research team
Dahlia Tsakiropoulos (Manager)
Involvement by work package
WP1 – assisting with legal and administrative project management and coordination
WP6 – disseminate results and help manage the intellectual property