Myocardial Infarction Clinical Trial
— BAMIOfficial title:
The Effect of Intracoronary Reinfusion of Bone Marrow-derived Mononuclear Cells(BM-MNC) on All Cause Mortality in Acute Myocardial Infarction.
Verified date | April 2021 |
Source | Queen Mary University of London |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a multinational, multicentre, randomised open-label, controlled, parallel-group phase III study. Its aim is to demonstrate that a single intracoronary infusion of autologous bone marrow-derived mononuclear cells is safe and reduces all-cause mortality in patients with reduced left ventricular ejection fraction(</=45%) after successful reperfusion for acute myocardial infarction when compared to a control group of patients undergoing best medical care.
Status | Completed |
Enrollment | 375 |
Est. completion date | November 27, 2019 |
Est. primary completion date | November 27, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - signed and dated informed consent form - men and women of any ethnic origin aged=18years - patients with acute ST-elevation myocardial infarction as defined by the universal definition of AMI (including new LBBB) - Patients with acute ST-elevation myocardial infarction as defined by the universal definition of AMI. - Successful acute reperfusion therapy (residual stenosis visually <50% and TIMI flow =2) within 24 hours of symptom onset or thrombolysis within 12 hours of symptom onset followed by successful percutaneous coronary intervention (PCI) within 24 hours after thrombolysis - Left ventricular ejection fraction = 45% with significant regional wall motion abnormality assessed by quantitative echocardiography (central, independent core lab analysis) 2 to 6 days after reperfusion therapy - Open coronary artery suitable for cell infusion supplying the target area of abnormal wall motion Exclusion Criteria: - Participation in another clinical trial within 30 days prior randomisation unless non interventional trials or trials where patients are randomised to only standard care and this has been discussed and agreed with the CI/sponsor prior to consenting - Previously received stem/progenitor cell therapy - Pregnant or nursing women - Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study or to follow the protocol - Necessity to revascularise additional vessels, outside the target coronary artery at the time of progenitor cell infusion (additional revascularisations after primary PCI and before BM-MNC cell infusion are allowed), unless clinically indicated and according to latest guidelines. This decision should be made at the time of the index procedure and explicitly stated at that time. - Cardiogenic shock requiring mechanical support - Platelet count <100.000/µl, or hemoglobin <8.5 g/dl - Impaired renal function, i.e. creatinine >2.5 mg/dl - Fever or diarrhoea not responsive to treatment within 4 weeks prior screening - Cliinically significant bleeding disorder within 3 months prior screening - Uncontrolled hypertension (systolic >180 mmHg and diastolic >120 mmHg) - Life expectancy of less than two years from any non-cardiac cause or uncontrolled neoplastic disease |
Country | Name | City | State |
---|---|---|---|
Belgium | Cardiovascular Research Centre VZW | Aalst | |
Belgium | Katholieke Universiteit Leuven | Leuven | |
Czechia | Fakultni Nemocnice BRNO | Brno | |
Denmark | Region Hovedstaden | Copenhagen | |
Finland | Kuopio University Hospital | Kuopio | |
Germany | Zentralklinik Bad Berka | Bad Berka | |
Germany | Universitätsmedizin Charité Berlin | Berlin | |
Germany | UniLinikum Bonn | Bonn | |
Germany | Universtitatsklinikum Dusseldorf, Klinik fur Kardiologie, Pneumologie und Angiologie | Dusseldorf | |
Germany | HELIOS Klinikum Erfurt GmbH | Erfurt | |
Germany | University Hospital Essen | Essen | |
Germany | Johann Wolfgang Goethe Universitaet Frankfurt AM MAIN | Frankfurt | |
Germany | Klinikum Fulda gAG | Fulda | |
Germany | Universitatsmedizin Greifswald Klinik Und Poliklinik Innere Med | Greifswald | |
Germany | UKSh Campus Lubeck, Med. Klinik II | Lubeck | |
Germany | Krankenhaus Hetzelstift Neustadt | Neustadt | |
Germany | SRH Zentralklinikum Suhl GmbH | Suhl | |
Germany | University Hospital Ulm, Clinic of Internal Medicine II | Ulm | |
Italy | Universita Cattolica Del Sacro Cuore | Rome | |
Netherlands | UMC Utrecht | Utrecht | |
Spain | Fundacion Jimenez Diaz | Madrid | |
Spain | Hospital Universitario Clinico San Carlos | Madrid | |
Spain | Hospital Universitario Fundacion Alcorcon | Madrid | |
Spain | Hospital Universitario La Princesa | Madrid | |
Spain | Servico Madrileno De Salud | Madrid | |
Spain | Hospital Clinico Salamanca | Salamanca | |
Spain | H.U. Marques de Valdecilla | Santander | |
Spain | Hospital Universitario Virgen del Rocio | Sevilla | |
Spain | Hospital Clinico Universitario De Valladolid | Valladolid | |
Spain | Hospiatl Universitatio Miguel Servet | Zaragoza | |
Switzerland | Cardiocentro Ticino | Lugano | |
United Kingdom | Queen Mary, University of London (QMUL) | London | |
United Kingdom | New Cross Hospital, Royal Wolverhampton NHS Trust | Wolverhampton |
Lead Sponsor | Collaborator |
---|---|
Queen Mary University of London |
Belgium, Czechia, Denmark, Finland, Germany, Italy, Netherlands, Spain, Switzerland, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time from randomization to all-cause death | for an average of 3 years | ||
Secondary | Time from randomization to cardiac death | for an average of 3 years | ||
Secondary | time from randomization to cardiovascular rehospitalisation | time from randomization to cardiovascular rehospitalisation for recurrent MI, coronary revascularisation procedures, heart failure, Implantation of ICD.CRT device, stroke, syncope or Arrhythmias | for an average of 3 years | |
Secondary | incidence and severity of adverse events | for an average of 3 years | ||
Secondary | bleeding by BARC definition | for an average of 3 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06013813 -
Conventional vs. Distal Radial Access Outcomes in STEMI Patients Treated by PCI
|
N/A | |
Completed |
NCT04507529 -
Peer-mentor Support for Older Vulnerable Myocardial Infarction Patients
|
N/A | |
Recruiting |
NCT06066970 -
Cardiac Biomarkers for the Quantification of Myocardial Damage After Cardiac Surgery
|
||
Recruiting |
NCT03620266 -
Effects of Bilberry and Oat Intake After Type 2 Diabetes and/or MI
|
N/A | |
Completed |
NCT04097912 -
Study to Gather Information to What Extent Patients Follow the Treatment Regimen of Low-dose Aspirin for Primary and Secondary Prevention of Diseases of the Heart and Blood Vessels
|
||
Completed |
NCT04153006 -
Comparison of Fingerstick Versus Venous Sample for Troponin I.
|
||
Completed |
NCT03668587 -
Feasibility and Security of a Rapid Rule-out and rule-in Troponin Protocol in the Management of NSTEMI in an Emergency Departement
|
||
Recruiting |
NCT01218776 -
International Survey of Acute Coronary Syndromes in Transitional Countries
|
||
Completed |
NCT03076801 -
Does Choral Singing Help imprOve Stress in Patients With Ischemic HeaRt Disease?
|
N/A | |
Recruiting |
NCT05371470 -
Voice Analysis Technology to Detect and Manage Depression and Anxiety in Cardiac Rehabilitation
|
N/A | |
Recruiting |
NCT04562272 -
Attenuation of Post-infarct LV Remodeling by Mechanical Unloading Using Impella-CP
|
N/A | |
Completed |
NCT04584645 -
A Digital Flu Intervention for People With Cardiovascular Conditions
|
N/A | |
Active, not recruiting |
NCT04475380 -
Complex All-comers and Patients With Diabetes or Prediabetes, Treated With Xience Sierra Everolimus-eluting Stents
|
||
Not yet recruiting |
NCT06007950 -
Time-restricted Eating Study (TRES): Impacts on Anthropometric, Cardiometabolic and Cardiovascular Health
|
N/A | |
Withdrawn |
NCT05327855 -
Efficacy and Safety of OPL-0301 Compared to Placebo in Adults With Post-Myocardial Infarction (MI)
|
Phase 2 | |
Recruiting |
NCT02876952 -
High Intensity Aerobic Interval Training With Mediterranean Diet Recommendations in Post-Myocardial Infarct Patients
|
N/A | |
Completed |
NCT02917213 -
Imaging Silent Brain Infarct And Thrombosis in Acute Myocardial Infarction
|
||
Completed |
NCT02711631 -
Feasibility and Effectiveness of Remote Virtual Reality-Based Cardiac Rehabilitation
|
N/A | |
Completed |
NCT02382731 -
Interventions to Support Long-Term Adherence aNd Decrease Cardiovascular Events Post-Myocardial Infarction
|
N/A | |
Completed |
NCT02305602 -
A Study of VentriGel in Post-MI Patients
|
Phase 1 |