Reperfusion Injury, Myocardial
Conditions
Keywords
melatonin, Reperfusion Injury, myocardial infarction
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.
Interventions
DRUGmelatonin (Helsinn Chemical Co, Biasca, Switzerland)
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).
DRUGPlacebos
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).
Sponsors
Chinese PLA General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The salvage index | 3 months after primary percutaneous coronary intervention | The salvage index measured by cardiac magnetic resonance |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The final infarct size | 3 months after primary percutaneous coronary intervention | The final infarct size measured by cardiac magnetic resonance |
| major adverse cardiovascular events (MACE) | 3 months after primary percutaneous coronary intervention | recurrent myocardial infarction, recurrent angina, revascularization, heart failure, cardiac death. |
| treatment-emergent adverse events (TEAEs) | 3 months after primary percutaneous coronary intervention | hypoglycemia, nausea |
Countries
China
Contacts
Primary Contactwei ren chen, M.D.
Outcome results
None listed