Positive Effect of Ischemic Postconditioning During Acute Myocardial Infarction
2 other identifiers
interventional
46
1 country
1
Brief Summary
The purpose of this study is to determine whether brief periods of ischemia performed just at the time of reperfusion -postconditioning- can reduce coronary endothelial dysfunction and infarct size in humans
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Sep 2006
Longer than P75 for phase_1
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
First Submitted
Initial submission to the registry
June 2, 2006
CompletedFirst Posted
Study publicly available on registry
June 5, 2006
CompletedStudy Start
First participant enrolled
September 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2011
CompletedOctober 23, 2012
October 1, 2012
3.8 years
June 2, 2006
October 22, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
coronary reserve after intracoronary adenosine injection
Immediately after the postconditioning procedure
Secondary Outcomes (5)
frequencies of low reflow and slow reflow situation
after postconditioning
regression of ST elevation
1h and 24h after postconditioning
left ventricular systolic function by Doppler tissue imaging (DAY 1 and 6)
day 1 and 6
left ventricular systolic function by RMN
day 8-12
myocardial blush
after postconditioning
Study Arms (2)
- Control
PLACEBO COMPARATOR-postconditioning group
EXPERIMENTALInterventions
patients were treated by repeated cycles of cycles of reperfusion/ischemia at the end of the procedure within the first minute after reperfusion
Percutaneous coronary interventions were performed following international guidelines. No additional intervention was performed in the control group.
Eligibility Criteria
You may qualify if:
- Acute myocardial infarction (\<6 hours)
- Occlusion of a major coronary vessel
You may not qualify if:
- History of previous myocardial infarction
- History of Coronary Artery Bypass Grafting
- Need for Coronary Artery Bypass Grafting
- Stenosis not eligible for angioplasty
- Limited ischemic area
- Cardiogenic shock
- Interventricular septum rupture
- Mitral regurgitation\>2
- Ventricular tachycardia
- Atrioventricular block class II and III
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Henri Mondor University Hospital
Créteil, 94010, France
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Philippe Le Corvoisier, MD
Henri Mondor University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 2, 2006
First Posted
June 5, 2006
Study Start
September 1, 2006
Primary Completion
July 1, 2010
Study Completion
November 1, 2011
Last Updated
October 23, 2012
Record last verified: 2012-10