Effects of Melatonin on Reperfusion Injury
Keywords
Abstract
Dates
| Last Verified: | 09/30/2017 |
| First Submitted: | 10/01/2017 |
| Estimated Enrollment Submitted: | 10/03/2017 |
| First Posted: | 10/05/2017 |
| Last Update Submitted: | 10/03/2017 |
| Last Update Posted: | 10/05/2017 |
| Actual Study Start Date: | 10/31/2017 |
| Estimated Primary Completion Date: | 10/31/2019 |
| Estimated Study Completion Date: | 10/31/2019 |
Condition or disease
Intervention/treatment
Drug: Melatonin group
Drug: Control group
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Experimental: Melatonin group Patients will receive a total intravenous melatonin dose of 11.61 mg (aproximately 166 μg/kg). | Drug: Melatonin group 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). |
| Placebo Comparator: Control group Patients will receive the same dose of placebo. | Drug: Control group 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). |
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| Criteria | 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 |
Outcome
Primary Outcome Measures
1. The salvage index [3 months after primary percutaneous coronary intervention]
Secondary Outcome Measures
1. The final infarct size [3 months after primary percutaneous coronary intervention]
2. major adverse cardiovascular events (MACE) [3 months after primary percutaneous coronary intervention]
3. treatment-emergent adverse events (TEAEs) [3 months after primary percutaneous coronary intervention]
