Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2026-01-09 @ 11:46 PM
Study NCT ID:
NCT00669227
Status:
COMPLETED
Last Update Posted:
2014-06-10
First Post:
2008-04-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intracoronary Stem Cell Therapy in Patients With Acute Myocardial Infarction (SCAMI)
Sponsor:
University of Ulm
Organization:
Study Overview
Official Title:
Intracoronary Stem Cell Therapy in Patients With Acute Myocardial Infarction - A Randomized, Double-blind, Placebo Controlled Trial (SCAMI)
Status:
COMPLETED
Status Verified Date:
2014-06
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:
SCAMI
Brief Summary:
Autologous stem cells may improve myocardial regeneration after intracoronary administration in patients with acute myocardial infarction. The primary hypothesis of this prospective, placebo-controlled, double-blind trial is that the increase of ejection fraction determined by magnetic resonance imaging between baseline and 6 months follow-up is superior in active treated patients compared to patients receiving placebo. The study includes an integrated pilot phase of 40 patients for evaluation of left ventricular ejection fraction determined by cardiac magnetic resonance imaging. Based on the data of this analysis the final sample size will be calculated. The primary endpoint is the improvement in left ventricular ejection fraction with an assumed 2.5% higher improvement in the cell treated population compared to the placebo treated group.
Detailed Description:
There is a 2:1 randomization for bone marrow cell therapy versus placebo therapy. Patients will be stratified according to age, localization of myocardial infarction and left ventricular function.
Study Oversight
Has Oversight DMC:
False
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?: