Ciclosporin A and Acute Myocardial Infarction

Sponsor

Hospices Civils de Lyon (Other)

Overall Status

Unknown status

CT.gov ID

NCT00403728

Collaborator

(none)

Enrollment

Location

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Myocardial Infarction	Drug: ciclosporine A	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single

Primary Purpose:

Treatment

Official Title:

Protection by Ciclosporine A During Reperfused Acute Myocardial Infarction.

Study Start Date :

Sep 1, 2004

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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