Bone Marrow-Derived Stem Cell Transfer in Acute Myocardial Infarctions
A Double-blind, Randomised, Controlled Study of Autologous Bone Marrow-Derived Stem Cell Transfer In Patients With ST-Segment Elevation Myocardial Infarction.
1 other identifier
interventional
68
1 country
1
Brief Summary
The benefit of reperfusion therapies for ST-elevation acute myocardial infarction (STEMI) is limited by postinfarction left ventricular (LV) dysfunction.The purpose of this study is to determine whether intracoronary transfer of bone marrow cells will augment left ventricular function recovery of the heart.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started May 2003
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2005
CompletedFirst Submitted
Initial submission to the registry
December 9, 2005
CompletedFirst Posted
Study publicly available on registry
December 12, 2005
CompletedJanuary 17, 2013
December 1, 2005
December 9, 2005
January 16, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
increase in global LV ejection fraction fraction; evaluation by magnetic resonance (MRI) after 4 months
Secondary Outcomes (2)
change in infarct size and regional LV function; evaluation by magnetic resonance (MRI) after 4 months
change in myocardial perfusion and oxidative metabolism; investigated using serial 1-[11C]acetate positron emission tomography after 4 months
Interventions
Eligibility Criteria
You may qualify if:
- patients with acute myocardial infarction with cumulative ST-segment elevation \>=6mm, successful epicardial reperfusion after PCI and significant LV dysfunction
You may not qualify if:
- patients presenting within 2 hours of symptom onset (no dilution of any treatment effect from aborted infarctions)
- patients with prior coronary artery bypass grafting, pulmonary edema, cardiogenic shock or significant co-morbidities
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Cardiology, University Hospital Gasthuisberg
Leuven, 3000, Belgium
Related Publications (1)
Janssens S, Dubois C, Bogaert J, Theunissen K, Deroose C, Desmet W, Kalantzi M, Herbots L, Sinnaeve P, Dens J, Maertens J, Rademakers F, Dymarkowski S, Gheysens O, Van Cleemput J, Bormans G, Nuyts J, Belmans A, Mortelmans L, Boogaerts M, Van de Werf F. Autologous bone marrow-derived stem-cell transfer in patients with ST-segment elevation myocardial infarction: double-blind, randomised controlled trial. Lancet. 2006 Jan 14;367(9505):113-21. doi: 10.1016/S0140-6736(05)67861-0.
PMID: 16413875RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stefan Janssens, MD, PhD
Department of Cardiology, University Hospital Gasthuisberg, Leuven, Belgium
- STUDY DIRECTOR
Frans Van de Werf, MD, PhD
Department of Cardiology, University Hospital Gasthuisberg, Leuven, Belgium
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
December 9, 2005
First Posted
December 12, 2005
Study Start
May 1, 2003
Study Completion
December 1, 2005
Last Updated
January 17, 2013
Record last verified: 2005-12