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NCT Number: NCT00669227

Intracoronary Stem Cell Therapy in Patients With Acute Myocardial Infarction (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.

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Key information

Conditions

Acute Myocardial Infarction Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

35 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Ulm

Ulm, 89081, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

autologous stem cells

Other

intracoronary administration at the same day of cell aspiration using the stop flow technique

Placebo Suspension

Other

intracoronary administration at the same day as cell aspiration

Primary outcomes

  1. difference in left ventricular ejection fraction measured by magnetic resonance imaging at baseline and 6 months follow-up

    Time frame: 6 months

Secondary outcomes

  1. left ventricular ejection fraction measured by magnetic resonance imaging

    Time frame: 1, 3, 12 months

  2. left ventricular enddiastolic volume measured by magnetic resonance imaging

    Time frame: 1, 3, 6, 12 months

  3. left ventricular endsystolic volume measured by magnetic resonance imaging

    Time frame: 1, 3, 6, 12 months

  4. major adverse cardiac events

    Time frame: 1, 3, 6, 12 months

Sponsors and collaborators

Lead sponsor

University of Ulm

Other

Registry information

Official study title

Intracoronary Stem Cell Therapy in Patients With Acute Myocardial Infarction - A Randomized, Double-blind, Placebo Controlled Trial (SCAMI)

Acronym: SCAMI

Important dates

Study start
2005
Primary completion
2009
First posted
Apr 30, 2008
Registry last updated
Jun 10, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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