Coronary Artery Disease Clinical Trial
Official title:
The Effect of Melatonin on the Outcomes of Myocardial Ischemia/Reperfusion Injury During Coronary Artery Bypass Grafting Surgery
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.
Status | Not yet recruiting |
Enrollment | 22 |
Est. completion date | September 2023 |
Est. primary completion date | July 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 30 Years to 70 Years |
Eligibility | 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. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Ain Shams University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | LVEF% | left ventricular ejection fraction | 24 hours | |
Other | Safety (Adverse effects from melatonin) | Safety of melatonin | 5 days | |
Other | hospital length of stay | Duration of staying in hospital | 5-7 days | |
Other | ICU length of stay | Duration of staying in ICU | 2-3 days | |
Primary | Nuclear factor-kB (NF-?B) | Nuclear factor-kappa B (NF-?B) 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 | 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. | 24 hours | |
Secondary | Tumor necrosis factor alpha TNF-a | 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. | 24 hours | |
Secondary | cardiac troponins | cardiac marker | 24 hours |
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