Intracoronary Infusion of BM-Derived Mononuclear Cells in Patients With Large Acute Myocardial Infarction
NCT ID: NCT00497211
Last Updated: 2007-07-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
INTERVENTIONAL
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
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Intracoronary mononuclear cell infusion
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
20 Years
80 Years
ALL
No
Sponsors
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University Hospital, Antwerp
OTHER
Principal Investigators
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Steven E Haine, MD
Role: PRINCIPAL_INVESTIGATOR
UZ Antwerpen
Chris Vrints, MD, PhD
Role: STUDY_DIRECTOR
UZ Antwerpen
Locations
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Universitair Ziekenhuis Antwerpen
Edegem, , Belgium
Countries
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Central Contacts
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Other Identifiers
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EC 3/39/123
Identifier Type: -
Identifier Source: org_study_id