Effects of Melatonin on Reperfusion Injury

Study Overview
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Brief Summary
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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.

Official Title
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Effects of Melatonin on Reperfusion Injury in Patients With ST-segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention

Conditions
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Reperfusion Injury, Myocardial

Intervention / Treatment
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* Drug: melatonin (Helsinn Chemical Co, Biasca, Switzerland)
* Drug: Placebos


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Melatonin group<br>Patients will receive a total intravenous melatonin dose of 11.61 mg (aproximately 166 μg/kg). | Drug: melatonin (Helsinn Chemical Co, Biasca, Switzerland)<br>* Patients will receive a total intravenous melatonin (Helsinn Chemical Co, Biasca, Switzerland) dose of 11.61 mg (aproximately 166 μg/kg). The dose will be distributed in a volume of 500 ml of an isotonic and sterile solution of 100 μM melatonin during 150 min with a drip rate of 4.2 ml/min. The temporal distribution of perfusion will be: 30 min previous to percutaneous revascularization and remainder doses in a subsequent 120 min (1 h during the angioplasty +60 min post-intervention).<br>* Other names: melatonin;|
| Placebo Comparator: Control group<br>Patients will receive the same dose of placebo. | Drug: Placebos<br>* The temporal distribution of perfusion will be: 30 min previous to percutaneous revascularization and remainder doses in a subsequent 120 min (1 h during the angioplasty +60 min post-intervention).<br>* Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The salvage index | The salvage index measured by cardiac magnetic resonance | 3 months after primary percutaneous coronary intervention | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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melatonin, Reperfusion Injury, myocardial infarction