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

September 4, 2014 updated by: University Hospital, Grenoble

Double-Blind Phase II Pilot Monocentric Randomized Clinical Trial Evaluating the Effect of a Preliminary Administration of Cyclosporine on Different Markers of Cardiac Ischemia Led by the Aortic Cross-clamp During Coronary Artery Bypass Surgery With Cardiopulmonary Bypass.

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 2

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

  • France
      • Grenoble,, France, 38043
        • Department of cardiac surgery - University Hospital of Grenoble

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: cyclosporin
Intravenous cyclosporin injection.
Drug: Sandimmum
Intravenous injection of cyclosporine
Placebo Comparator: Pacebo
Intravenous injection of NaCl solution.
Drug: Placebo
Intravenous Injection of NaCl solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Area under curve and maximal blood level of both troponin-T and Creatine Kinase-MB after cardiopulmonary bypass
Time Frame: at anaesthesia (ti), at the end of the cardiopulmonary bypass (t0), and 6 h, 12 h, 24 h,48h and 72h after the end of the cardiopulmonary bypass.
at anaesthesia (ti), at the end of the cardiopulmonary bypass (t0), and 6 h, 12 h, 24 h,48h and 72h after the end of the cardiopulmonary bypass.

Secondary Outcome Measures

Outcome Measure
Time Frame
Area under curve and maximal blood level of S100β protein
Time Frame: at anaesthesia (ti), at the end of the cardiopulmonary bypass (t0), and 6 h, 12 h, 24 h,48h and 72h after the end of the cardiopulmonary bypass
at anaesthesia (ti), at the end of the cardiopulmonary bypass (t0), and 6 h, 12 h, 24 h,48h and 72h after the end of the cardiopulmonary bypass
Spontaneous defibrillation at aorta declamping; Post surgical atrial fibrillation; ECG (new Q wave); Transthoracic Echocardiogram (diastolic and systolic function study, research of paradoxical septal motion, study of cardiac output)....)
Time Frame: until Day 3 after the end of the cardiopulmonary bypass
until Day 3 after the end of the cardiopulmonary bypass
Levels of inflammatory cytokines (TNF alpha , IL-1 alpha et IL-1 beta, IL-6, IL-8, IL-10). C-reactive protein (CRP) level
Time Frame: until day 8 after the end of the cardiopulmonary bypass
until day 8 after the end of the cardiopulmonary bypass
Creatine blood levels
Time Frame: until 3 months after the end of the cardiopulmonary bypass
until 3 months after the end of the cardiopulmonary bypass

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Investigators

  • Principal Investigator: Vincent BACH, MD, Cardiac Surgery Department - University Hospital of Grenoble,

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.

General Publications

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

April 1, 2009

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

October 26, 2009

First Submitted That Met QC Criteria

October 26, 2009

First Posted (Estimate)

October 27, 2009

Study Record Updates

Last Update Posted (Estimate)

September 5, 2014

Last Update Submitted That Met QC Criteria

September 4, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DCIC 08 04

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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