E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Acute myocardial infarction |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10000891 |
E.1.2 | Term | Acute myocardial infarction |
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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 |
This study is a pilot towards testing the hypothesis that high flow oxygen in the routine management of ST elevation myocardial infarction (STEMI) is harmful as measured by the risk of death, complications and infarct size.
Endpoints: • Mortality at 30 days • 30 day major adverse cardiac events (MACE) • Infarct size measured by Troponin T, Brain Natriuretic peptide (BNP) level and Magnetic Resonance Imaging (MRI)
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E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Subjects are eligible to be included in the study if they meet all of the following criteria:
(1) Present with ST-Elevation Myocardial Infarction based on the disease diagnostic criteria (see below)
(2) Are at least 18 years of age and competent to provide written informed consent before entering the study. Informed consent must be signed by the study participant.
Disease Diagnostic Criteria
For the purposes of this study, STEMI will include:
A history of chest discomfort or ischaemic symptoms of > 20 minutes duration, < 12 hours prior to randomisation and one of the following present on at least one ECG prior to randomisation
• ST-segment elevation > 1mm in two or more contiguous limb leads or > 2mm in two or more precordial leads.
• New or presumably new left bundle branch block (LBBB)
• ST-segment depression > 1mm in two anterior precordial leads (V1 through V4) with clinical history and evidence suggestive of true posterior infarction.
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E.4 | Principal exclusion criteria |
4.3 Exclusion Criteria
(1) Severe Chronic Obstructive Pulmonary Disease (COPD) (2) Known previous myocardial infarction or CABG; Q waves on ECG in territory other than that of presentation myocardial infarction (3) Previous bleomycin treatment (4) Subjects who are not to be admitted to the coronary care unit. (5) Participants who are immediate family members of investigator site personnel directly affiliated with study, whether biological or legally adopted. (6) Women who are known to be pregnant (7) Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study (8) Cardiogenic shock (systolic blood pressure less than 90 mm Hg lasting more than 30 mins with evidence of tissue hypoperfusion as defined as cold peripheries (extremities colder than core), oliguria (<30 mL/h), or both) at the time of presentation to the emergency department (9) Severe arterial hypoxaemia (oxygen saturation ≤85%) at time of presentation
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E.5 End points |
E.5.1 | Primary end point(s) |
Endpoints: • Mortality at 30 days • 30 day major adverse cardiac events (MACE) • Infarct size measured by troponin T, BNP level and MRI
The study will be used as a pilot for a large multicentre study of the effect of the routine use of high flow oxygen in myocardial infarction.
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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 | Yes |
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 | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
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 |
High dose versus titrated dose oxygen |
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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 | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
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 | 2 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |