Treatment with melatonin to patients with heart infarction.

Phase 1

Conditions: Acute Myocardial Infarction
MedDRA version: 18.1Level: PTClassification code 10000891Term: Acute myocardial infarctionSystem Organ Class: 10007541 - Cardiac disorders
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Registration Number: EUCTR2010-022400-53-DK

Lead Sponsor: Køge Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

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

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary end point(s): MRI-scan of the heart to examine the infarct size (area of necrosis) in the myocardium<br><br><br><br><br>;Main Objective: MRI to examine myocardial infarct size, area at risk and myocardial salvage index. MRI is to be performed on day 4 (+/-1). <br>;Secondary Objective: Hs-Troponin T<br>Creatinin Kinase Myocardial Band<br>Plasma level of melatonin postoperative<br>Plasma level of AOPP, MPO and MDA postoperative<br>Clinical events within the first 90 days post-operatively;Timepoint(s) of evaluation of this end point: 4 days (+/-1 days)

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Blood markers:<br>Hs-Troponin T<br>Creatinin Kinase Myocardial Band<br>AOPP<br>MDA<br>MPO<br>melatonin<br>Clinical events within the first 90 days post-operatively<br>;Timepoint(s) of evaluation of this end point: Clinical events within the first 90 days post-operatively<br><br>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. <br>AOPP, MDA, MPO and melatonin: postoperative<br>