Investigating the effect of melatonin on myocardial tissue when administered before cardiac surgery in adults.

Phase 2

Recruiting

Conditions: myocardial reperfusion injury
oxidative damage
inflammation
Cardiovascular - Coronary heart disease
Cardiovascular - Other cardiovascular diseases

Registration Number: ACTRN12621000543886

Lead Sponsor: Sir Charles Gairdner Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 114

Inclusion Criteria

1.Aged between 18 and 90 years.
2.Undergoing elective cardiac surgery, requiring cardiopulmonary bypass (coronary artery bypass grafting (CABG)) at Sir Charles Gairdner Hospital and Saint John of God Subiaco.
3.Being willing and able to provide informed consent.

Exclusion Criteria

Patients will be ineligible for study entry if they have concomitant hepatic failure, an autoimmune disease or the inability to give informed consent. Patients on immunosuppressive drugs, oral contraceptives, fluvoxamine, and those consuming melatonin within two weeks before the operation, will also be excluded.
The exclusion criteria further includes patients who are pregnant, breastfeeding, and those requiring urgent or emergency surgery (resulting in insufficient time to take melatonin).

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assessment of high-sensitivity troponin (hsTnT) levels by serum assay analysis.<br><br>It is designed to have 80% power to detect a small effect size (25% decrease in TnT levels from the control group). [ This will be tested pre-operatively (to determine a baseline value) and at 6h, 12h and 24 hours following surgery.]

Secondary Outcome Measures

Name	Time	Method
Assessment of plasma melatonin levels, following two different preoperative melatonin dosages, by mass spectrometry. [ Pre-operative (baseline), intra-operative and 6 hours post-operative levels.];Inflammatory markers as reflected by CRP. The CRP will be measured from a blood sample.[ Pre-operative (baseline), intra-operative and 6, 12 and 24 hours post-operative levels.]