Ciclosporin A and Acute Myocardial Infarction - Full Text View

Purpose

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.

Condition	Intervention	Phase
Myocardial Infarction	Drug: ciclosporine A	Phase II Phase III

MedlinePlus related topics:

Heart Attack

ChemIDplus related topics:

Cyclosporine Cyclosporin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Placebo Control, Parallel Assignment

Official Title:	Protection by Ciclosporine A During Reperfused Acute Myocardial Infarction.

Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:

Infarct size evaluated primarily by the area under the curve of CK and troponin I release over the first 72 hours of reperfusion.

Secondary Outcome Measures:

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

Estimated Enrollment:	60
Study Start Date:	September 2004

Eligibility

Ages Eligible for Study:	18 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00403728

Locations


France
	Michel Ovize
	Lyon, France, 69677

Sponsors and Collaborators

Hospices Civils de Lyon

Investigators


Principal Investigator:	Michel Ovize, MD	Hospices Civils de Lyon

More Information

Study ID Numbers:	2004.353
First Received:	November 24, 2006
Last Updated:	April 26, 2007
ClinicalTrials.gov Identifier:	NCT00403728
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Hospices Civils de Lyon:

Ischemia

Reperfusion

Myocardial infarction

ciclosporin A

acute myocardial infarction

Study placed in the following topic categories:

Necrosis

Cyclosporine

Heart Diseases

Clotrimazole

Miconazole

Myocardial Ischemia

Tioconazole

Vascular Diseases

Ischemia

Infarction

Cyclosporins

Myocardial Infarction

Additional relevant MeSH terms:

Anti-Infective Agents

Molecular Mechanisms of Pharmacological Action

Immunologic Factors

Physiological Effects of Drugs

Enzyme Inhibitors

Immunosuppressive Agents

Pharmacologic Actions

Pathologic Processes

Antifungal Agents

Therapeutic Uses

Cardiovascular Diseases

Antirheumatic Agents

Dermatologic Agents

ClinicalTrials.gov processed this record on October 03, 2008

Sponsored by:	Hospices Civils de Lyon
Information provided by:	Hospices Civils de Lyon
ClinicalTrials.gov Identifier:	NCT00403728