Effect of Preliminary Administration of Cyclosporine (Sandimmun ®) on Different Markers of Cardiac Ischaemia Induced by Cardiopulmonary Bypass

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2011-07-31

Brief Summary

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Observe the effect of preliminary cyclosporine administration on different markers of cardiac ischaemia led by the aortic cross-clamp during coronary artery bypass surgery with Cardiopulmonary bypass.

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Detailed Description

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The coronary artery bypass surgery, in spite of substantial improvements during the last years, is still associated to a post-operative mortality and morbidity: myocardial infarction, heart failure, cardiac arrhythmia, renal failure, Stroke.

These complications are often due to ischaemia - reperfusion injury event. Recent studies showed that in case of cellular stress (in particular during the reperfusion after ischaemia) a not specific pore, called Mitochondrial permeability transition Pore (MPTP), could be opened. That caused the loss of ion homeostasis, then cell death as well as by apoptosis as by necrosis.

Prevent the opening of this MPTP during the myocardial reperfusion after coronary bypass, for example, is an important objective to improve the cardioprotection.

The Cyclosporin A, prevents the MPTP from opening. Several studies have shown an cytoprotection led by cyclosporin A, after ischaemia reperfusion in several models as isolated rats heart, in vivo rats heart and ex vivo myocardial ( atrial ) human tissues.

Recently, a multicentric study performed in humans, during the acute phase of myocardial infarction, showed a reduction of infarct size by approximately 40% in the cyclosporine group compared to control group.

Conditions

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Coronary Artery Bypass Surgery Cardiopulmonary Bypass

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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cyclosporin

Intravenous cyclosporin injection.

Group Type ACTIVE_COMPARATOR

Sandimmum

Intervention Type DRUG

Intravenous injection of cyclosporine

Pacebo

Intravenous injection of NaCl solution.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Intravenous Injection of NaCl solution

Interventions

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Sandimmum

Intravenous injection of cyclosporine

Intervention Type DRUG

Placebo

Intravenous Injection of NaCl solution

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patient hospitalized for a coronary artery bypass surgery
* Not urgent surgery
* Left ventricular ejection fraction (LVEF)\> 40 %
* 18 years and older
* patient who have sign the informed consent form
* Affiliation to the French Social Security.

Exclusion Criteria

* Beating heart surgery with or without Cardiopulmonary Bypass
* Patient receiving another surgical gesture combined to the CABG
* Myocardial infarction or vascular cerebral attack less than 30 days
* Previous History of cardiac surgery;
* Renal failure (creatinine \> 200 µmol/l)
* Uncontrolled hypertension
* hyperkaliemy;
* hyperuricemy;
* Acute Coronary Syndrome
* Malignant tumor
* Unchecked infection
* Previous intravenous administration of Sandimmun ®;
* allergy to ciclosporin, ethyl alcohol, castor oil or nitrogen
* Pregnant Woman, parturient without contraception, or breast-feeding
* Age \< 18 years
* Patient who have not signed the form of consent;
* Patient Under guardianship or being the object of a legal protective measure

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No