Melatonin Impact on the Outcomes of Myocardial Ischemia/Reperfusion Injury During Coronary Artery Bypass Grafting Surgery

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-31

Study Completion Date

2023-09-30

Brief Summary

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The ischemia/reperfusion (I/R) injury of the myocardium initiates a variety and complex sets of inflammatory reactions that may both exaggerate local injury as well as provoke injury of distant organ function . I/R injuries are the main causes of heart failure, morbidity, and mortality after cardiac surgery such as coronary artery bypass graft (CABG surgery) . The reactive oxygen species are believed to be excessively elevated during coronary artery bypass surgery (CABG) due to compromised free radical scavenging mechanism in the myocardium that can make myocardium highly susceptible to oxidative stress and inflammation and result in reperfusion injury .

Melatonin and its metabolites protect against inflammation by regulating several inflammatory cytokines. Additionally, melatonin is a free radical scavenger and an antioxidant agent.

the current study is designed to investigate the protective effects of melatonin against myocardial I/R injury in patients undergoing coronary artery bypass grafting (CABG) surgery.

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Detailed Description

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Myocardial ischemia is a situation where there is an inadequate blood and oxygen supply to the heart muscles due to partial or complete obstruction of the coronary arteries, predisposing the affected cardiac muscle to death. Hence, restoration of blood supply is critical to reestablish myocardial reperfusion. The ischemia/reperfusion (I/R) injury of the myocardium initiates a variety and complex sets of inflammatory reactions that may both exaggerate local injury as well as provoke injury of distant organ function . I/R injuries are the main causes of heart failure, morbidity, and mortality after cardiac surgery such as coronary artery bypass graft (CABG surgery) . The reactive oxygen species are believed to be excessively elevated during coronary artery bypass surgery (CABG) due to compromised free radical scavenging mechanism in the myocardium that can make myocardium highly susceptible to oxidative stress and inflammation and result in reperfusion injury . Strategies to improve the CABG related complications are much needed to augment the positive outcomes in the post-operative surviving patients. There are various therapeutic approaches to decrease or ameliorate myocardial I/R injury, these include reperfusion controlling, cardioprotective events and management via various interventions.

Melatonin (N-acetyl 5-methoxy-tryptamine) is mainly secreted by the pineal gland to regulate sleep. Since 1993 when melatonin was first reported, a wide range of melatonin functions have been directly confirmed by multiple scientific studies . Melatonin and its metabolites protect against inflammation by regulating several inflammatory cytokines. Additionally, melatonin is a free radical scavenger and an antioxidant agent. Early studies have shown that melatonin exerts beneficial effects in the context of renal I/R, myocardial I/R, and hepatic I/R. The ability to protect against I/R injury may relate to the functions of melatonin as both an anti-inflammatory and an antioxidant agent .

Some authors show an anti-apoptotic action of melatonin in different organs of the body, such as thymus, kidney, brain and liver .

the current study is designed to investigate the protective effects of melatonin against myocardial I/R injury in patients undergoing coronary artery bypass grafting (CABG) surgery.

Conditions

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Coronary Artery Bypass Grafting Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Melatonin group

Melatonin Group (n=11) patients will receive 60 mg/day Melatonin capsule (M1) from the day five before surgery.

Group Type ACTIVE_COMPARATOR

Melatonin

Intervention Type DIETARY_SUPPLEMENT

patients in the melatonin group will receive 60 mg/day Melatonin capsule (M1) from the day five before surgery.

Control group

Control group (n=11) patients will receive placebos with the same appearances and packaging at the same dose and time as those in the melatonin group.

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

patients will receive capsules of the same size and color

Interventions

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Melatonin

patients in the melatonin group will receive 60 mg/day Melatonin capsule (M1) from the day five before surgery.

Intervention Type DIETARY_SUPPLEMENT

placebo

patients will receive capsules of the same size and color

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients who will undergo elective CABG,
* ready to participate in the study and
* can be reached by phone

Exclusion Criteria

* • Patients who will require urgent surgery and won't have adequate time to take medications for 5 days,

* Re-operative patients (CABG),
* Off-pump CABG,
* Patients who have concomitant renal failure,
* Patients with severe respiratory problems.
* Patients with previous stroke or significant cerebrovascular disease,
* Patients with hepatitis b,c and HIV.
* Inflammatory disease ex. Rheumatoid arthritis, psoriasis…,
* Patients with ejection fraction (EF%) lower than 40%,
* Patients undergo CABG surgery with simultaneous heart valve repair or replacement, resection of a ventricular aneurysm, or other operations.
* Pregnancy and lactation.

Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No