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Intracoronary Stem Cells in Large Myocardial Infarction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00389545
Recruitment Status : Unknown
Verified October 2006 by Charles University, Czech Republic.
Recruitment status was:  Active, not recruiting
First Posted : October 19, 2006
Last Update Posted : October 19, 2006
Sponsor:
Information provided by:
Charles University, Czech Republic

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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria

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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00389545


Sponsors and Collaborators
Charles University, Czech Republic
Investigators
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Principal Investigator: Martin Penicka Charles University, Prague, Czech Republic
More Information
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ClinicalTrials.gov Identifier: NCT00389545    
Other Study ID Numbers: IGA 8225
First Posted: October 19, 2006    Key Record Dates
Last Update Posted: October 19, 2006
Last Verified: October 2006
Additional relevant MeSH terms:
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Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
 Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases