Intracoronary Stem Cells in Large Myocardial Infarction
Recruitment status was Active, not recruiting
| Tracking Information | |||||
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| First Received Date ICMJE | October 18, 2006 | ||||
| Last Updated Date | October 18, 2006 | ||||
| Start Date ICMJE | Not Provided | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Intracoronary Stem Cells in Large Myocardial Infarction | ||||
| Official Title ICMJE | Intracoronary Stem Cells in Large Myocardial Infarction | ||||
| 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 |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Myocardial Infarction | ||||
| Intervention ICMJE | Procedure: Intracoronary infusion of autologous bone-marrow derived stem cells | ||||
| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Enrollment ICMJE | Not Provided | ||||
| Completion Date | Not Provided | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 79 Years | ||||
| Accepts Healthy Volunteers | Not Provided | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Not Provided | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00389545 | ||||
| Other Study ID Numbers ICMJE | IGA 8225 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | Charles University, Czech Republic | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Charles University, Czech Republic | ||||
| Verification Date | October 2006 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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