Text Size

Intracoronary Stem Cells in Large Myocardial Infarction

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2006 by Charles University, Czech Republic.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Charles University, Czech Republic
ClinicalTrials.gov Identifier:
NCT00389545
First received: October 18, 2006
Last updated: NA
Last verified: October 2006
History: No changes posted
  Purpose

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 Intervention Phase
Myocardial Infarction
 Procedure: Intracoronary infusion of autologous bone-marrow derived stem cells
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intracoronary Stem Cells in Large Myocardial Infarction

Resource links provided by NLM:

MedlinePlus related topics: Heart Attack
U.S. FDA Resources

Further study details as provided by Charles University, Czech Republic:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00389545

Sponsors and Collaborators
Charles University, Czech Republic
Investigators
Principal Investigator: Martin Penicka Charles University, Prague, Czech Republic
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00389545     History of Changes
Other Study ID Numbers: IGA 8225
Study First Received: October 18, 2006
Last Updated: October 18, 2006
Health Authority: Czech Republic: SUKL

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
 Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 19, 2013