An interventional study of Melatonin and placebo in Coronary Artery Bypass Grafting and Coronary Artery Disease, sponsored by Ain Shams University. Status unknown. Open to participants aged 30 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-09-23.
Sponsored by Ain Shams University · Not applicable, Interventional, and Treatment
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.
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.
5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.
This study's planned enrollment of 22 is below the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Ain Shams University is the lead sponsor of 1,876 studies on the registry; 423 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Patients who will require urgent surgery and won't have adequate time to take medications for 5 days,
Melatonin Group (n=11) patients will receive 60 mg/day Melatonin capsule (M1) from the day five before surgery.
Dietary Supplement: Melatonin
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
patients in the melatonin group will receive 60 mg/day Melatonin capsule (M1) from the day five before surgery.
patients will receive capsules of the same size and color
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
Time frame: 24 hours
interleukin 6 il-6
Interleukin-6 is a widely used cytokine that causes inflammation and oxidative stress, which would further result in cardiac and cerebral injury. The increased expression of interleukin-6 is closely related to atherosclerosis, myocardial infarction, heart failure and ischemic stroke. It is a key risk factor for these diseases by triggering inflammatory reaction and inducing other molecules release.
Time frame: 24 hours
Tumor necrosis factor alpha TNF-α
Tumor necrosis factor (TNF) is a multifunctional cytokine that plays important roles in diverse cellular events such as cell survival, proliferation, differentiation, and death. As a pro-inflammatory cytokine, TNF is secreted by inflammatory cells, which may be involved in inflammation-associated heart diseases.
Time frame: 24 hours
cardiac troponins
cardiac marker
Time frame: 24 hours
LVEF%
left ventricular ejection fraction
Time frame: 24 hours
Safety (Adverse effects from melatonin)
Safety of melatonin
Time frame: 5 days
hospital length of stay
Duration of staying in hospital
Time frame: 5-7 days
ICU length of stay
Duration of staying in ICU
Time frame: 2-3 days
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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Ain Shams University