Comparing the Protective Effects of Two Cardioplegic Solutions, on Cardiac Metabolism, as Assessed Using Microdialysis (Cardioplégie)

Centre Hospitalier Universitaire de Saint Etienne

Status and phase: Completed; Phase 3

Conditions: Coronary Artery Stenosis

Treatments: Drug: St Thomas; Drug: Custodiol

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01401140

2009-A00506-51 (Other Identifier)

0908033

Details and patient eligibility

About

An estimated 8% to 15% of patients hospitalized for a coronary pathology undergo coronary revascularization surgery with extracorporeal circulation (ECC). (1) Like most major cardiac surgical interventions, it is performed with the heart stopped; this leads to more or less severe myocardial ischemia. The heart is stopped (and therefore deprived of oxygen) for a duration that varies depending on the number of bypasses required, and on the local difficulties encountered. On average, myocardial ischemia lasts between 20 and 80 minutes. Heart protection during coronary revascularization surgery remains a crucial factor in limiting the heart's aerobic function during aortic clamping, and in minimizing the resulting post-operatory ventricular dysfunction. Its quality is a determining factor of the post-operatory issue.

High-performance heart protection solutions such as Custodiol have been used by heart surgeons for a few years. They are used as an alternative choice to other cardioplegic solutions, the efficacy of which has already been proven (St Thomas). These two myocardial protection solutions have never been evaluated in an in vivo, randomized, comparative trial.

Full description

Myocardial microdialysis is the state-of-the-art technique for evaluating the protective effects of cardioplegic solutions; it enables physicians to monitor oxidation-reduction muscle metabolism during an ongoing operation.

Enrollment: 29 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient was referred to the Cardiovascular Surgery Unit for surgical coronary revascularization
• Patient has anterior interventricular stenosis
• Patient signed the informed consent form
• Patient is covered by health insurance

Exclusion criteria

• Patients with beating heart surgery indication (no extracorporeal circulation required)
• Emergency surgery and patients who suffered myocardial infarction less than a week before surgery
• Iterative surgery

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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29 participants in 2 patient groups

St Thomas

Active Comparator group

Treatment:

Drug: St Thomas

Custodiol

Experimental group

Treatment:

Drug: Custodiol