Effects of Melatonin on Reperfusion Injury

Chinese PLA General Hospital (301 Hospital)

Status: Unknown

Conditions: Reperfusion Injury, Myocardial

Treatments: Drug: Placebos; Drug: melatonin (Helsinn Chemical Co, Biasca, Switzerland)

Study type: Interventional

Funder types: Other

Identifiers

NCT03303378

MelonRI

Details and patient eligibility

About

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.

Enrollment: 190 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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190 participants in 2 patient groups, including a placebo group

Melatonin group

Experimental group

Description:

Patients will receive a total intravenous melatonin dose of 11.61 mg (aproximately 166 μg/kg).

Treatment:

Drug: melatonin (Helsinn Chemical Co, Biasca, Switzerland)

Control group

Placebo Comparator group

Description:

Patients will receive the same dose of placebo.

Treatment:

Drug: Placebos