E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Acute Myocardial Infarction |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cardiovascular Diseases [C14] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10000891 |
E.1.2 | Term | Acute myocardial infarction |
E.1.2 | System Organ Class | 10007541 - Cardiac disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
MRI to examine myocardial infarct size, area at risk and myocardial salvage index. MRI is to be performed on day 4 (+/-1).
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E.2.2 | Secondary objectives of the trial |
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 |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.
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E.4 | Principal 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 |
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E.5 End points |
E.5.1 | Primary end point(s) |
MRI-scan of the heart to examine the infarct size (area of necrosis) in the myocardium
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | 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
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E.5.2.1 | 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
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The end of the trial is: Clinical events after 90 days post-operatively for the last subject undergoing the trial. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |