Intracoronary Stem Cell Therapy in Patients With Acute Myocardial Infarction (SCAMI)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jochen Wohrle, University of Ulm
ClinicalTrials.gov Identifier:
NCT00669227
First received: April 28, 2008
Last updated: June 7, 2014
Last verified: June 2014

April 28, 2008
June 7, 2014
October 2005
January 2009   (final data collection date for primary outcome measure)
difference in left ventricular ejection fraction measured by magnetic resonance imaging at baseline and 6 months follow-up [ Time Frame: 6 months ] [ Designated as safety issue: No ]
left ventricular ejection fraction measured by magnetic resonance imaging [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00669227 on ClinicalTrials.gov Archive Site
  • left ventricular ejection fraction measured by magnetic resonance imaging [ Time Frame: 1, 3, 12 months ] [ Designated as safety issue: No ]
  • left ventricular enddiastolic volume measured by magnetic resonance imaging [ Time Frame: 1, 3, 6, 12 months ] [ Designated as safety issue: No ]
  • left ventricular endsystolic volume measured by magnetic resonance imaging [ Time Frame: 1, 3, 6, 12 months ] [ Designated as safety issue: No ]
  • major adverse cardiac events [ Time Frame: 1, 3, 6, 12 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Intracoronary Stem Cell Therapy in Patients With Acute Myocardial Infarction (SCAMI)
Intracoronary Stem Cell Therapy in Patients With Acute Myocardial Infarction - A Randomized, Double-blind, Placebo Controlled Trial (SCAMI)

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Acute Myocardial Infarction
  • Coronary Artery Disease
  • Other: autologous stem cells
    intracoronary administration at the same day of cell aspiration using the stop flow technique
  • Other: placebo suspension
    intracoronary administration at the same day as cell aspiration
  • Active Comparator: 1
    autologous stem cells, Ficoll preparation, intracoronary administration at the same day of bone marrow cell aspiration
    Intervention: Other: autologous stem cells
  • Placebo Comparator: 2
    placebo is visually indistinguishable from verum due to integration of autologous erythrocytes, intracoronary administration the same day of bone marrow aspiration
    Intervention: Other: placebo suspension

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
42
Not Provided
January 2009   (final data collection date for primary outcome measure)

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
Both
35 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00669227
SCAMI 01-04
No
Jochen Wohrle, University of Ulm
University of Ulm
Not Provided
Principal Investigator: Jochen Wöhrle, MD; FESC University of Ulm
University of Ulm
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP