Intracoronary Infusion of BM-Derived Mononuclear Cells in Patients With Large Acute Myocardial Infarction
The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2007 by University Hospital, Antwerp.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
University Hospital, Antwerp
Information provided by:
University Hospital, Antwerp
ClinicalTrials.gov Identifier:
NCT00497211
First received: July 4, 2007
Last updated: July 5, 2007
Last verified: July 2007
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Purpose
Large acute myocardial infarctions are the most frequent cause of subsequent systolic heart failure. Some evidence exists on the improvement after intracoronary administration of bone marrow cells in patients with a recente acute myocardial infarction. Although subgroup analyses suggest that patients with the largest myocardial infarctions have the largest increase in ejection fraction after intracoronary bone marrow administration, there is no published trial including only large myocardial infarctions. Therefor we sought to confirm the subgroup analyses by conducting a trial in only large first acute myocardial infarction patients.
| Condition | Intervention | Phase |
|---|---|---|
|
Myocardial Infarction |
Procedure: Intracoronary mononuclear cell infusion |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
Resource links provided by NLM:
Further study details as provided by University Hospital, Antwerp:
Eligibility| Ages Eligible for Study: | 20 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Age ≥20 and <80 years old
- Acute myocardial infarction >2 and <96 hours from start to reperfusion
- Cumulative ST-segment elevation >6 mm on 12 lead ECG
- No functional myocardial impairment outside the myocardial infarction region
- Succesful PCI of infarct related coronary artery
- Left ventricular ejection fraction <50% on ventriculography, echo or MRI
- Accepted anticonceptive use during the study for women of childbearing potential
- Written and signed informed consent
Exclusion Criteria:
- CPR > 10 minuts or persistent cardiogenic shock
- complete left bundle branch block without concordant ST-segment elevation
- Need foor cardiac surgery (valvular, coronary or other)
- Trombocytopenia, coagulation disorders or hematological disease
- History or active malignancy
- Life expectancy (apart from acute myocardial infarction) <5 years
- Dialysis or severe kidney insufficiency (creatinin clearance <30ml/')
- Severe liver insufficiency
- Severe respiratory disease
- Systemic inflammatory pathology (acute or chronic, apart from inflammation associated with myocardial infarction)
- Symptomatic cerebral or periferal vascular disease
- Prior myocardial infarction or prior myocardial dysfunction
- Prior CABG or heart valve surgery
- Pregnancy, pregnancy wish or lactation <1 month
- Psychiatrical illness
- Physical or psychological inability to adhere to the protocol
- Participation in other not yet completed study
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00497211
Contacts
| Contact: Steven E Haine, MD | 0032.3.821.42.81 | steven.haine@uza.be |
| Contact: Myriam Michiels, Nurse | 0032.3.821.33.04 | Myriam.michiels@uza.be |
Locations
| Belgium | |
| Universitair Ziekenhuis Antwerpen | Recruiting |
| Edegem, Belgium, 2650 | |
| Sub-Investigator: Johan Bosmans, MD, PhD | |
| Sub-Investigator: Marc Claeys, MD, PhD | |
| Sub-Investigator: Hielko Miljoen, MD, PhD | |
Sponsors and Collaborators
University Hospital, Antwerp
Investigators
| Principal Investigator: | Steven E Haine, MD | UZ Antwerpen |
| Study Director: | Chris Vrints, MD, PhD | UZ Antwerpen |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00497211 History of Changes |
| Other Study ID Numbers: | EC 3/39/123 |
| Study First Received: | July 4, 2007 |
| Last Updated: | July 5, 2007 |
| Health Authority: | Belgium: Institutional Review Board |
Keywords provided by University Hospital, Antwerp:
|
First large acute myocardial infarction |
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 21, 2013