REPAIR-AMI: Intracoronary Progenitor Cells in Acute Myocardial Infarction (AMI)

A. M. Zeiher

Status and phase

Completed

Phase 3

Conditions

Myocardial Infarction

Treatments

Biological: Placebo medium supplemented with autologous serum

Biological: Intracoronary infusion of enriched bone marrow-derived progenitor cells

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00279175

Paul-Ehrlich-Institute 1034/01

EudraCT 2006-000250-43

2/04

Details and patient eligibility

About

Impaired contractile function after a heart attack of the heart is a major cause of "heart failure" limiting quality of life and prognosis, which cannot be prevented even with optimal standard therapy, including immediate balloon/stent dilation of the infarct vessel.

The aim of the REPAIR-AMI trial is to investigate whether infusion of progenitor cells into the infarct vessel (after successful reperfusion therapy) may improve left ventricular contractile function compared to placebo therapy. After bone marrow aspiration progenitor cells are enriched via a centrifugation method.

Full description

The study is a double-blind, placebo-controlled, randomized, multicenter trial.
Patients after an acute myocardial infarction, undergoing successful reperfusion therapy are included.
All patients undergo bone marrow aspiration 3 to 6 days after the infarction.
After cell processing, enriched bone marrow-derived progenitor cells or placebo medium is infused direct into the infarct related artery during stop-flow. In addition, a left ventricular angiography is performed.
After 4 months left ventricular angiography is repeated. The primary endpoint is the difference in change of left ventricular ejection fraction between the two groups.

Enrollment

204 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients with acute myocardial infarction (ST elevation in at least 2 leads >= 0.2 mV in V1,V2 or V3 or >= 0.1 mV in other leads), treated by one of the following procedures
- Either acute PCI with stent implantation within 24 hours after symptom onset or
- treatment with thrombolysis within 12 hours of symptom onset followed by PCI with stent implantation within 24 hours after thrombolysis.
Acute PCI / stent implantation has been successful (residual stenosis visually < 30% and TIMI flow >= 2).
At the time of inclusion patient does no longer require i.v. catecholamines or mechanical hemodynamic support (aortic balloon pump)
Significant regional wall motion abnormality in LV angiogram at the time of acute PCI (ejection fraction <= 45% on visual estimation).
Maximal CK elevation >= 400 U/l (measured at 37° C) with significant MB fraction > 6%
Age 18 - 80 Years
Written informed consent

Exclusion criteria

Regional wall motion abnormality outside the area involved in the index acute myocardial infarction.
Need to revascularize additional vessels, outside the infarct artery.
Arteriovenous malformations or aneurysms
Active infection (CRP > 10 mg/dl) now, or fever or diarrhea within last 4 weeks.
Chronic inflammatory disease
HIV infection or active hepatitis
Neoplastic disease without documented remission within the past 5 years.
Cerebrovascular insult within 3 months
Impaired renal function (creatinine > 2 mg/dl) at the time of cell therapy
Significant liver disease (GOT > 2x upper limit) or spontaneous INR > 1,5)
Anemia (hemoglobin < 8.5 mg/dl)
Platelet count < 100.000/µl
Hypersplenism
Known allergy or intolerance to clopidogrel, heparin or abciximab.
History of bleeding disorder
Gastrointestinal bleeding within 3 months
Major surgical procedure or traumata within 2 months
Uncontrolled hypertension
Pregnancy
Mental retardation
Previously performed stem / progenitor cell therapy
Participation in another clinical trial within the last 30 days.