Acute Myocardial Infarction MedDRA version: 18.1 Level: PT Classification code 10000891 Term: Acute myocardial infarction System Organ Class: 10007541 - Cardiac disorders
Conditions
Interventions
Product Name: Melatonin
Product Code: Melatonin
Pharmaceutical Form: Powder for solution for injection
CAS Number: 73-31-4
Other descriptive name: MELATONIN
Pharmaceutical form of the placebo: Solutio
Sponsors
Køge Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Adults who are able to give informed consent 1 significant coronary occlusion (>2mm) expected to undergo PCI. ECG inclusion criterion: The occlusion must be ECG-verified with new ST-elevations = 0.2 mV in V2-V3 and/or = 0.1 in the other leads or new onset of left bundle branch block. If we during the primary PCI find an acute occlusion of a larger (> 2 mm) coronary artery with TIMI 0-1 the patient can be included in the trial even though the patient does not meet the ECG inclusion criterion. Having onset of symptoms of qualifying AMI and undergo PCI within 6 hours. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 15 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 25
Exclusion criteria
Exclusion criteria: Patients with prior myocardial infarction, more than one significant occlusion, prehospital thrombolysis, known history of renal failure, history of autoimmune diseases, pregnancy, fertile women or breastfeeding, severe concurrent illness with reduced short-term prognosis, pacemaker, claustrophobia, cardiogenic shock, metals in the body, atrial fibrillation, BMI = 40
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): MRI-scan of the heart to examine the infarct size (area of necrosis) in the myocardium ;Main Objective: MRI to examine myocardial infarct size, area at risk and myocardial salvage index. MRI is to be performed on day 4 (+/-1). ;Secondary Objective: Hs-Troponin T Creatinin Kinase Myocardial Band Plasma level of melatonin postoperative Plasma level of AOPP, MPO and MDA postoperative Clinical events within the first 90 days post-operatively;Timepoint(s) of evaluation of this end point: 4 days (+/-1 days) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Blood markers: Hs-Troponin T Creatinin Kinase Myocardial Band AOPP MDA MPO melatonin Clinical events within the first 90 days post-operatively ;Timepoint(s) of evaluation of this end point: Clinical events within the first 90 days post-operatively Hs-Troponin T and Creatinin Kinase Myocardial Band: baseline (before the procedure), 6 hour, 24 hours, 48 hours, 72 hours and 96 hours after the procedure. AOPP, MDA, MPO and melatonin: postoperative | — |
Countries
Denmark
Outcome results
None listed