Effects of Melatonin on Reperfusion Injury

Not Applicable

• Conditions: Reperfusion Injury, Myocardial
• Interventions: Drug: Placebos; Drug: melatonin (Helsinn Chemical Co, Biasca, Switzerland)

• Registration Number: NCT03303378
• Lead Sponsor: Chinese PLA General Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-10
• Study First Submitted: 2017-10-02
• Study First Submitted QC: 2017-10-04
• Last Update Submitted: 2017-10-04
• Study First Posted: 2017-10-06
• Last Update Posted: 2017-10-06
• Study Start: 2017-11-01
• Primary Completion: 2019-11-01
• Study Completion: 2019-11-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 190

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Placebos	Patients will receive the same dose of placebo.
Melatonin group	melatonin (Helsinn Chemical Co, Biasca, Switzerland)	Patients will receive a total intravenous melatonin dose of 11.61 mg (aproximately 166 μg/kg).

Primary Outcome Measures

Name	Time	Method
The salvage index	3 months after primary percutaneous coronary intervention	The salvage index measured by cardiac magnetic resonance

Secondary Outcome Measures

Name	Time	Method
major adverse cardiovascular events (MACE)	3 months after primary percutaneous coronary intervention	recurrent myocardial infarction, recurrent angina, revascularization, heart failure, cardiac death.
The final infarct size	3 months after primary percutaneous coronary intervention	The final infarct size measured by cardiac magnetic resonance
treatment-emergent adverse events (TEAEs)	3 months after primary percutaneous coronary intervention	hypoglycemia, nausea

Trial Locations

Locations (1)

PLA General Hospital; 🇨🇳 Beijing, Beijing, China