Ignite Creation Date:
2024-05-05 @ 4:36 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00279175
Status:
COMPLETED
Last Update Posted:
2012-09-20
First Post:
2006-01-18
Brief Title:
REPAIR-AMI Intracoronary Progenitor Cells in Acute Myocardial Infarction AMI
Sponsor:
A M Zeiher
Organization:
Johann Wolfgang Goethe University Hospital
Study Overview
Official Title:
Reinfusion of Enriched Progenitor Cells And Infarct Remodeling in Acute Myocardial Infarction REPAIR - AMI
Status:
COMPLETED
Status Verified Date:
2012-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 including immediate balloonstent 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
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
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 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EudraCT 2006-000250-43 | None | None | None |
| Paul-Ehrlich-Institute 103401 | None | None | None |