Ciclosporin A and Acute Myocardial Infarction
Protection by Ciclosporine A During Reperfused Acute Myocardial Infarction.
1 other identifier
interventional
60
1 country
1
Brief Summary
Beyond its immunosuppressive properties, ciclosporine A (CsA) can also inhibit the opening of a mitochondrial mega-channel called the permeability transition pore (mPTP). Opening of the mPTP plays a key role in cardiomyocyte death during reperfusion following a prolonged ischemic insult. Ciclosporin A has been shown to reduce infarct size when administered at reperfusion in experimental models. The objective of the present study is to determine whether administration of CsA at reperfusion in patients with ongoing acute myocardial infarction treated by coronary angioplasty might reduce infarct size.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
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
September 1, 2004
CompletedFirst Submitted
Initial submission to the registry
November 24, 2006
CompletedFirst Posted
Study publicly available on registry
November 27, 2006
CompletedApril 27, 2007
April 1, 2007
November 24, 2006
April 26, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Infarct size evaluated primarily by the area under the curve of CK and troponin I release over the first 72 hours of reperfusion.
Secondary Outcomes (3)
Myocardial contractile reserve assessed by dobutamine echocardiography at day 5.
No reflow evaluated by MRI at day 5
Recovery of myocardial contraction assessed by echocardiography and MRI at month 3
Interventions
Eligibility Criteria
You may qualify if:
- Male and female patients, aged more than 18, with suspected first acute myocardial infarction
- Within 12 hours of the onset of chest pain
- With a need for emergency revascularization by angioplasty. Patients must display a fully occluded (TIMI zero flow) culprit coronary artery, absence of visible collaterals and exhibit TIMI flow \>2 after direct stenting by angioplasty.
You may not qualify if:
- Hypersensibility to ciclosporine A
- Cardiac arrest or cardiogenic shock
- Immunosuppressive disease (\< 6 months): cancers, lymphomas, positive serology for HIV, hepatitis, etc.
- Known renal failure or serum creatinine \> 120 µmole/l at admission
- Liver failure
- Uncontrolled hypertension
- Current pregnancy or women without contraception
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Michel Ovize
Lyon, 69677, France
Related Publications (1)
Mewton N, Croisille P, Gahide G, Rioufol G, Bonnefoy E, Sanchez I, Cung TT, Sportouch C, Angoulvant D, Finet G, Andre-Fouet X, Derumeaux G, Piot C, Vernhet H, Revel D, Ovize M. Effect of cyclosporine on left ventricular remodeling after reperfused myocardial infarction. J Am Coll Cardiol. 2010 Mar 23;55(12):1200-1205. doi: 10.1016/j.jacc.2009.10.052.
PMID: 20298926DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michel Ovize, MD
Hospices Civils de Lyon
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
November 24, 2006
First Posted
November 27, 2006
Study Start
September 1, 2004
Last Updated
April 27, 2007
Record last verified: 2007-04