E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Acute ST elevation myocardial infaction |
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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.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To study whether 10 l/min O2 vs no supplemental O2 in the ambulance will result in different infarct size after acute balloon angioplasty (PCI) for ST elevation myocardial infarction |
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E.2.2 | Secondary objectives of the trial |
To study in the same patients whether 10 l/min O2 vs no supplemental O2 in the ambulance will result in different chest pain and perceived health at 6 months. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- STEMI patient transported with ambulance to SUS Lund, SUS Malmö or Helsingborg hospital and accepted for acute PCI - Symptom duration less than 6 hours - Normal saturation (≥ 94 %) measured with pulse oximeter - Informed consent
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E.4 | Principal exclusion criteria |
- Previous myocardial infarction - Inability to make decision to participate; dementia and the like - For cardiac magnetic resonance imaging (CMR): Significant claustrophobia, prostheses or other magnetic material inside the body
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E.5 End points |
E.5.1 | Primary end point(s) |
Myocardial salvage index on CMR |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
At day 4-6 after inclusion |
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E.5.2 | Secondary end point(s) |
- Infarct size on CMR - Area at risk on CMR - Ejection fraction on CMR - Microvascular obstruction on CMR - Pain difference (visual analog scale) at randomization vs at PCI balloon inflation start - Doses of opioids (substance and mg) and betablockers (substance and mg) given before and during the PCI - Infarct size as measured in-hospital with area under Troponin T curve (first 24 h). - ST-resolution after PCI - Coronary blood flow (TIMI flow) during PCI - Use of heart failure medications (beta blockers, ACEI, ARB, diuretics, digoxin and sinus node inhibitors etc) at 6 months - Perceived health (EQ-5D) at 6 months For the Echocardiography subgroup - Change in wall motion score index on echocardiography from index hospitalization to 6 months |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
During ambulance transport, at day 4-6 after inclusion and at 6 months |
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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 | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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 | Yes |
E.8.1.4 | Double blind | No |
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 | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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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
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | No |
E.8.5.1 | Number of sites anticipated in the EEA | 3 |
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 | No |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |