Heart Failure Clinical Trial
— RACE-STEMIOfficial title:
The Impact of Repeated Intracoronary Injection of Autologous Bone-marrow Derived Mononuclear Cells for Left Ventricle Contractility and Remodeling in Patients With STEMI.Prospective Randomized Study.
This is multicentre, randomised open-label, controlled, parallel-group phase III study. Its aim is to demonstrate that a triple intracoronary infusion of autologous bone marrow-derived mononuclear cells in addition to state of the art treatment 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 | Not yet recruiting |
Enrollment | 200 |
Est. completion date | December 2022 |
Est. primary completion date | July 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Men and women of any ethnic origin aged = 18 years. 2. Patients with acute ST-elevation myocardial infarction as defined by the universal definition of AMI. 3. 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. 4. Left ventricular ejection fraction = 45% with significant regional wall motion abnormality assessed by quantitative echocardiography (central, independent core lab analysis) 3 to 6 days after reperfusion therapy 5. Open coronary artery suitable for cell infusion supplying the target area of abnormal wall motion 6. LVEF=45% with significant regional wall motion abnormality assessed by computed tomography (CT) 30 days after reperfusion therapy with no LVEF improvement =5%. Exclusion Criteria: 1. Participation in another clinical trial within 30 days prior to randomisation 2. Previously received stem/progenitor cell therapy 3. Pregnant or nursing women 4. Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study or to follow the protocol 5. Necessity to revascularise additional vessels, outside the target coronary artery at the time of BM-MNC infusion (additional revascularisations after primary PCI and before BM-MNC cell infusion are allowed) 6. Cardiogenic shock requiring mechanical support 7. Platelet count <100,000/µl, or hemoglobin <8.5 g/dl 8. Impaired renal function, i.e. serum creatinine >2.5 mg/dl 9. Persistent fever or diarrhea not responsive to treatment within 4 weeks prior screening 10. Clinically significant bleeding within 3 months prior screening 11. Uncontrolled hypertension (systolic >180 mmHg and diastolic >120 mmHg) 12. Life expectancy of less than 2 years from any non-cardiac cause or neoplastic disease |
Country | Name | City | State |
---|---|---|---|
Poland | Polsko-Amerykanskie Kliniki Serca | Ustron |
Lead Sponsor | Collaborator |
---|---|
American Heart of Poland |
Poland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Left ventricle ejection fraction change evaluated by CT | 12 months | ||
Secondary | Change in left ventricle End-Systolic Volume (ESV) and End-Diastolic Volume (EDV) evaluated by CT | 12 months | ||
Secondary | Time from randomisation to cardiac death | 3 years | ||
Secondary | Time from randomisation to cardiovascular death or rehospitalisation due to heart failure | 3 years | ||
Secondary | Incidence and severity of adverse events | 3 years |
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