Clinical trial NCT02152527: Prospective Observational Study of Trimetazidine Influence on Mitochondrial Metabolism in Human Heart Ventricle
Official title: Myocardial Energetics as a Target for Treatment of Ischemic Heart Disease: A Translational Approach From Patient to Mitochondria
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Lead sponsor: University of Split, School of Medicine
Sponsor class: OTHER
First posted: 2014-06-02
Enrollment: 55
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with coronary artery disease planned for coronary artery bypass grafting

Brief summary: Trimetazidine (1-\[2,3,4-trimethoxybenzyl\] piperazine dihydrochloride) is a clinically effective antianginal agent. Despite these clinical successes, the understanding of trimetazidine's mechanism of action remains incomplete, particularly influence of trimetazidine on mitochondrial function in isolated human cardiomyocytes. The investigators will perform this study to seek possible differences in mitochondrial respiration related to standard preoperative enrolled trimetazidine therapy.

Detailed description: Background:

Different types of medication are used for treatment of ischemic heart disease. One of recently developed drugs is trimetazidine. Although it clinical benefits are clear, mechanism by which this occurs is as yet undefined. In few animal studies authors try to define what effects trimetazidine has on both fatty acid and glucose metabolism in heart. Data collected from human cardiomyocytes are rare. Available data suggest that trimetazidine may act as a potent inhibitor of beta oxidation, with no significant effect on glucose oxidation.

Objective:

Primary objective: collection of mitochondrial respiration data using human heart ventricular samples. Secondary objective: define possible differences in mitochondrial respiration depending on preoperative trimetazidine usage.

Methods:

Regularly scheduled patients for coronary artery bypass grafting surgery who accept to participate in study will be enrolled in further protocol. Patients with inclusion criteria and without exclusion criteria will be enrolled in the study. At the end of operation, surgeon will take biopsy sample of left ventricle for mitochondrial function and metabolic activity analysis.

Eligibility criteria: Inclusion Criteria:

* Patients with coronary artery disease who are candidates for coronary artery bypass graft (CABG) surgery.

Exclusion Criteria:

* Emergency patients, patients who already had heart surgery, patients with acute coronary syndrome in last 2 months, patients with inability to understand patient information and informed consent.

Primary outcomes:
measure: Change in rate of myocardial oxygen consumption expressed in pmolO2/min/units of citrate synthase activity.
timeFrame: Within 24 hours after tissue biopsy
Secondary outcomes:
Other outcomes:
Locations:
city: Split
country: Croatia
facility: School of Medicine, University of Split
Study officials:
affiliation: Department of Physiology, University of Split School of Medicine
name: Marko Ljubković, M.D., PhD
role: PRINCIPAL_INVESTIGATOR
References: