Effects of Melatonin on Reperfusion Injury in Patients With ST-segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 190
- Locations
- 1
- Primary Endpoint
- The salvage index
Study Overview
Brief Summary
Acute myocardial infarction is a major cause of mortality and morbidity. Primary percutaneous coronary intervention (pPCI) is currently the most effective treatment strategy in acute myocardial infarction. However, a sizable number of patients fail to restore optimal myocardial reperfusion, mostly because of the 'no-reflow' phenomenon. Melatonin is the chief indoleamine produced by the pineal gland, and a well-known antioxidant and free radical scavenger. Several studies have shown that melatonin protects against ischemia/reperfusion injury (IRI). In our previous study, melatonin markedly reduced infarcted area, improved cardiac function and reduced lactate dehydrogenase release in rats. The investigators planned to research the cardioprotective effects of intravenous melatonin administered prior to reperfusion and continued after restoration of coronary blood flow in patients with ST segment elevation myocardial infarction undergoing pPCI.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •ST segment elevation myocardial infarction undergoing primary percutaneous poronary intervention
Exclusion Criteria
- •unconscious at presentation
- •had cardiogenic shock
- •had a history of myocardial infarction
- •stent thrombosis
- •renal insufficiency
- •had previously undergone coronary artery bypass surgery
Arms & Interventions
Melatonin group
Patients will receive a total intravenous melatonin dose of 11.61 mg (aproximately 166 μg/kg).
Intervention: melatonin (Helsinn Chemical Co, Biasca, Switzerland) (Drug)
Control group
Patients will receive the same dose of placebo.
Intervention: Placebos (Drug)
Outcomes
Primary Outcomes
The salvage index
Time Frame: 3 months after primary percutaneous coronary intervention
The salvage index measured by cardiac magnetic resonance
Secondary Outcomes
- major adverse cardiovascular events (MACE)(3 months after primary percutaneous coronary intervention)
- The final infarct size(3 months after primary percutaneous coronary intervention)
- treatment-emergent adverse events (TEAEs)(3 months after primary percutaneous coronary intervention)
Investigators
Chen Wei Ren, MD
doctor
Chinese PLA General Hospital