- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00403728
Ciclosporin A and Acute Myocardial Infarction
April 26, 2007 updated by: Hospices Civils de Lyon
Protection by Ciclosporine A During Reperfused Acute Myocardial Infarction.
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.
Study Overview
Study Type
Interventional
Enrollment
60
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Lyon, France, 69677
- Michel Ovize
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Infarct size evaluated primarily by the area under the curve of CK and troponin I release over the first 72 hours of reperfusion.
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Secondary Outcome Measures
Outcome Measure |
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Myocardial contractile reserve assessed by dobutamine echocardiography at day 5.
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No reflow evaluated by MRI at day 5
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Recovery of myocardial contraction assessed by echocardiography and MRI at month 3
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2004
Study Registration Dates
First Submitted
November 24, 2006
First Submitted That Met QC Criteria
November 24, 2006
First Posted (ESTIMATE)
November 27, 2006
Study Record Updates
Last Update Posted (ESTIMATE)
April 27, 2007
Last Update Submitted That Met QC Criteria
April 26, 2007
Last Verified
April 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Ischemia
- Pathologic Processes
- Necrosis
- Myocardial Ischemia
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Myocardial Infarction
- Infarction
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Antirheumatic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Dermatologic Agents
- Antifungal Agents
- Calcineurin Inhibitors
- Cyclosporine
- Cyclosporins
Other Study ID Numbers
- 2004.353
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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