Status:
COMPLETED
REPAIR-AMI: Intracoronary Progenitor Cells in Acute Myocardial Infarction (AMI)
Lead Sponsor:
A. M. Zeiher
Collaborating Sponsors:
Johann Wolfgang Goethe University Hospital
Blutspendedienst Baden-Württemberg - Hessen
Conditions:
Myocardial Infarction
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
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...
Detailed 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 patient...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
204 Patients enrolled
Trial Details
Trial ID
NCT00279175
Start Date
April 1 2004
End Date
December 1 2010
Last Update
September 20 2012
Active Locations (17)
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1
Zentralklinik Bad Berka
Bad Berka, Germany, 99437
2
Kerckhoff Klinik
Bad Nauheim, Germany, 61231
3
Herz- und Diabeteszentrum NRW
Bad Oeynhausen, Germany, 32545
4
BG Kliniken Bergmannsheil
Bochum, Germany, 44789