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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2009 by University of Ulm.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University of Ulm
ClinicalTrials.gov Identifier:
NCT00669227
First received: April 28, 2008
Last updated: April 6, 2009
Last verified: April 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Acute Myocardial Infarction
Coronary Artery Disease
 Other: autologous stem cells
Other: placebo suspension
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intracoronary Stem Cell Therapy in Patients With Acute Myocardial Infarction - A Randomized, Double-Blind, Placebo Controlled Trial (SCAMI)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Ulm:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 40
Study Start Date: October 2005
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
autologous stem cells, Ficoll preparation, intracoronary administration at the same day of bone marrow cell aspiration
 Other: autologous stem cells
intracoronary administration at the same day of cell aspiration using the stop flow technique
Placebo Comparator: 2
placebo is visually indistinguishable from verum due to integration of autologous erythrocytes, intracoronary administration the same day of bone marrow aspiration
 Other: placebo suspension
intracoronary administration at the same day as cell aspiration

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

Ages Eligible for Study:   35 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00669227

Locations
Germany
University of Ulm
Ulm, Germany, 89081
Sponsors and Collaborators
University of Ulm
Investigators
Principal Investigator: Jochen Wöhrle, MD; FESC University of Ulm
  More Information

No publications provided

Responsible Party: Jochen Wöhrle, MD, FESC, University of Ulm
ClinicalTrials.gov Identifier: NCT00669227     History of Changes
Other Study ID Numbers: SCAMI 01-04
Study First Received: April 28, 2008
Last Updated: April 6, 2009
Health Authority: Germany: Ethics Commission
Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Infarction
Myocardial Infarction
Heart Diseases
Cardiovascular Diseases
 Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Ischemia
Pathologic Processes
Necrosis

ClinicalTrials.gov processed this record on May 19, 2013