Clinical trial NCT00669227: Intracoronary Stem Cell Therapy in Patients With Acute Myocardial Infarction (SCAMI)
Official title: Intracoronary Stem Cell Therapy in Patients With Acute Myocardial Infarction - A Randomized, Double-blind, Placebo Controlled Trial (SCAMI)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Myocardial Infarction
Coronary Artery Disease
Lead sponsor: University of Ulm
Sponsor class: OTHER
First posted: 2008-04-30
Enrollment: 42
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* acute myocardial infarction with time to revascularization \>6 hours from symptom start
* clear target vessel
* large myocardial infarction defined as: proximal vessel occlusion, CK \> 1000 U/L, myocardial scar in magnetic resonance imaging \> 10% of left ventricular muscle mass
* potential prior thrombolysis
* written informed consent

Exclusion Criteria:

* acute myocardial infarction with revascularization within 6 hours after symptom start
* prior myocardial infarction
* no clear target vessel
* contraindication for magnetic resonance imaging (e.g. pacemaker, ICD)
* severely depressed left ventricular ejection fraction (less than 20% in magnetic resonance imaging)
* prior hematologic disease
* prior chemo therapy
* prior stem cell transplantation
* prior treatment with G-CSF
* known alteration of the bone marrow by alcohol or drugs, e.g. agranulocytosis
* local infection of puncture sites

Primary outcomes:
measure: difference in left ventricular ejection fraction measured by magnetic resonance imaging at baseline and 6 months follow-up
timeFrame: 6 months
Secondary outcomes:
measure: left ventricular ejection fraction measured by magnetic resonance imaging
timeFrame: 1, 3, 12 months
measure: left ventricular enddiastolic volume measured by magnetic resonance imaging
timeFrame: 1, 3, 6, 12 months
measure: left ventricular endsystolic volume measured by magnetic resonance imaging
timeFrame: 1, 3, 6, 12 months
measure: major adverse cardiac events
timeFrame: 1, 3, 6, 12 months
Other outcomes:
Locations:
city: Ulm
country: Germany
facility: University of Ulm
Study officials:
affiliation: University of Ulm
name: Jochen Wöhrle, MD; FESC
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wohrle J, Merkle N, Mailander V, Nusser T, Schauwecker P, von Scheidt F, Schwarz K, Bommer M, Wiesneth M, Schrezenmeier H, Hombach V. Results of intracoronary stem cell therapy after acute myocardial infarction. Am J Cardiol. 2010 Mar 15;105(6):804-12. doi: 10.1016/j.amjcard.2009.10.060.
citation: Wohrle J, von Scheidt F, Schauwecker P, Wiesneth M, Markovic S, Schrezenmeier H, Hombach V, Rottbauer W, Bernhardt P. Impact of cell number and microvascular obstruction in patients with bone-marrow derived cell therapy: final results from the randomized, double-blind, placebo controlled intracoronary Stem Cell therapy in patients with Acute Myocardial Infarction (SCAMI) trial. Clin Res Cardiol. 2013 Oct;102(10):765-70. doi: 10.1007/s00392-013-0595-9. Epub 2013 Jul 30.