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

NCT05552586 | Unknown DMC

• 1 other identifier: PHCL91
• Study Type: interventional
• Target: 22
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Coronary Artery Bypass Grafting; Coronary Artery Disease

Keywords

CABG; melatonin; inflammation

Outcome Measures

Primary Outcomes (1)

• Nuclear factor-kB (NF-κB)

  Nuclear factor-kappa B (NF-κB) is a ubiquitous transcription factor that is involved in inflammatory and immune responses, as well as in regulation of expression of many other genes related to cell survival, proliferation, and differentiation

  24 hours

Secondary Outcomes (3)

• interleukin 6 il-6

  24 hours

• Tumor necrosis factor alpha TNF-α

  24 hours

• cardiac troponins

  24 hours

Other Outcomes (4)

• LVEF%

  24 hours

• Safety (Adverse effects from melatonin)

  5 days

• hospital length of stay

  5-7 days

Study Arms (2)

Melatonin group

ACTIVE COMPARATOR

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

Dietary Supplement: Melatonin

Control group

PLACEBO COMPARATOR

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.

Other: placebo

Interventions

Melatonin DIETARY_SUPPLEMENT

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

Melatonin group

placebo OTHER

patients will receive capsules of the same size and color

Control group

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Related Publications (1)

• Casper EA, Wakeel LE, Sabri NA, Khorshid R, Gamal MA, Fahmy SF. Melatonin ameliorates inflammation and improves outcomes of ischemia/reperfusion injury in patients undergoing coronary artery bypass grafting surgery: a randomized placebo-controlled study. Apoptosis. 2025 Feb;30(1-2):267-281. doi: 10.1007/s10495-024-02040-6. Epub 2024 Dec 4.

  PMID: 39633112 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Inflammation

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• eman A. casper, masters

  Ain shams university , faculty of pharmacy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

eman A. casper, masters

CONTACT

0201068731483; drcasper912009@hotmail.com

sara M. Farid, PhD

CONTACT

01001232067; sarah.farid@pharma.asu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturerer

Study Record Dates

• First Submitted: September 21, 2022
• First Posted: September 23, 2022
• Study Start: October 1, 2022
• Primary Completion: July 1, 2023
• Study Completion: September 1, 2023
• Last Updated: September 23, 2022

Record last verified: 2022-09