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Intracoronary Stem Cells in Large Myocardial Infarction

Sponsor
Charles University, Czech Republic (Other)
Overall Status
Unknown status
CT.gov ID
NCT00389545
Collaborator
(none)

Study Details

Study Description

Brief Summary

Despite the widespread use of effective reperfusion therapies, the patients presenting late with large myocardial infarction have poor outcomes. The aim of the study was to investigate the safety and efficacy of intracoronary injection of autologous bone marrow-derived mononuclear cells (BMNCs) in patients with large myocardial infarction

Condition or Disease Intervention/Treatment Phase
  • Procedure: Intracoronary infusion of autologous bone-marrow derived stem cells
 Phase 2

Detailed Description

In the current era, up to 30% of patients with ST-segment elevation myocardial infarction, usually those presenting late, show ongoing left ventricular (LV) remodeling and poor clinical outcome despite primary percutaneous coronary intervention (PCI). Cardiac transfer of bone marrow-derived stem and progenitor cells has been investigated as an adjunctive therapy to promote regeneration of infarcted myocardium. Therefore, we designed a multicenter, randomized study to test the safety and efficacy of intracoronary injection of autologous BMNCs in patients with large acute anterior myocardial infarction and late presentation, who were treated with successful primary PCI.

Study Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Intracoronary Stem Cells in Large Myocardial Infarction

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 79 Years
    Sexes Eligible for Study:
    All
    Inclusion Criteria:
    • Patients with the first ST-segment elevation acute anterior myocardial infarction due to occlusion of the proximal left anterior ascending coronary artery (LAD), who will underwent successful primary stented PCI. Patients are eligible if they have primary PCI from 4 to 12 hours after symptoms onset and show reduced LV ejection fraction ≤ 45% with at least 3 akinetic segments in the LAD perfusion territory at echocardiogram performed 24 hours after PCI.
    Exclusion Criteria:
    • Exclusion criteria are age ≥ 80 years, cardiogenic shock (Killip IV), multivessel coronary artery disease, serious renal or hepatic disease, blood cells disorders, documented cancer or terminal illness.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Charles University, Czech Republic

    Investigators

    • Principal Investigator: Martin Penicka, Charles University, Prague, Czech Republic

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00389545
    Other Study ID Numbers:
    • IGA 8225
    First Posted:
    Oct 19, 2006
    Last Update Posted:
    Oct 19, 2006
    Last Verified:
    Oct 1, 2006
    Additional relevant MeSH terms:
    Myocardial Infarction
    Infarction

    Study Results

    No Results Posted as of Oct 19, 2006