Intracoronary Infusion of BM-Derived Mononuclear Cells in Patients With Large Acute Myocardial Infarction
Phase 2
- Conditions
- Myocardial Infarction
- Registration Number
- NCT00497211
- Lead Sponsor
- University Hospital, Antwerp
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- Not specified
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Universitair Ziekenhuis Antwerpen
🇧🇪Edegem, Belgium