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NCT00389545 Clinical Trial

Intracoronary Stem Cells in Large Myocardial Infarction

Myocardial Infarction Clinical Trial

Official title:
Intracoronary Stem Cells in Large Myocardial Infarction

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT00389545
Other study ID # IGA 8225
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received October 18, 2006
Last updated October 18, 2006

Study information
Verified date October 2006
Source Charles University, Czech Republic
Contact n/a
Is FDA regulated No
Health authority Czech Republic: SUKL
Study type Interventional

Clinical Trial 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

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender Both
Age group 18 Years to 79 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• Intracoronary infusion of autologous bone-marrow derived stem cells

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Charles University, Czech Republic
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