E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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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 | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10003601 |
E.1.2 | Term | Atherosclerosis |
E.1.2 | System Organ Class | 100000004866 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10011078 |
E.1.2 | Term | Coronary artery disease |
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 |
To determine if uptake of 18F-sodium fluoride, as detected by a PET scan, is associated with a greater chance of adverse heart events happening in the future in patients who have already had a heart attack. |
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E.2.2 | Secondary objectives of the trial |
To determine whether coronary 18F-sodium fluoride uptake: • Is associated with secondary clinical outcomes including all-cause death, cardiac death, non-fatal recurrent myocardial infarction and unscheduled coronary revascularization revascularisation. • Can identify areas of damaged plaque in a large population of patients across multiple centres. • Can predict which plaques might cause a future heart attack. • Can identify plaques which may show evidence of more rapid growth and hardening of the plaque (calcification).
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E.2.3 | Trial contains a sub-study | No |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Prediction of Recurrent Events with 18F-Fluoride to Identify Ruptured and High-risk Coronary Artery Plaques in Patients with Myocardial Infarction - The Investigation of TeMporal ChangE draft 3 2 Dec 2014 - this study is intended to assess the natural history of 18F-NaF uptake over time
Prediction of Recurrent Events with 18F-Fluoride to Identify Ruptured and High-risk Coronary Artery Plaques in Patients with Myocardial Infarction – REPROducibility Study - draft 3 2 December 2014 - this study is intended to assess the reproducibility of 18F-NaF uptake of repeat scans
Prediction of Recurrent Events with 18F-Fluoride to Identify Ruptured and High-risk Coronary Artery Plaques in Patients with Myocardial Infarction – In Vivo Multimodal IntrA-coronary ImaGing to Enable Plaque Characterisation - draft 4 2 December 2014 - this study is designed to determine the plaque features detected with invasive imaging tools that are associated with 18F-NaF uptake |
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E.3 | Principal inclusion criteria |
1. Patients aged ≥50 years with recent (<21 days) type 1 myocardial infarction and angiographically proven multi-vessel coronary artery disease defined as at least two major epicardial vessels with any combination of either (a) >50% luminal stenosis, or (b) previous revascularization (percutaneous coronary intervention or coronary artery bypass graft surgery). 2. Provision of informed consent prior to any study specific procedures
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E.4 | Principal exclusion criteria |
1. Inability or unwilling to give informed consent 2. Women who are pregnant, breastfeeding or of child-bearing potential (women who have experienced menarche, are pre-menopausal and have not been sterilised) will not be enrolled into the trial 3. Major intercurrent illness with life expectancy <2 year 4. Renal dysfunction (estimated glomerular filtration rate ≤30 mL/min/1.73 m2) 5. Contraindication to iodinated contrast agent, positron emission tomography or computed tomography 6. Permanent or persistent atrial fibrillation 7. Previous screening as part of the trial |
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E.5 End points |
E.5.1 | Primary end point(s) |
Cardiac death, non-fatal recurrent myocardial infarction, or unscheduled coronary revascularisation |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Time to event during participant follow-up period which will be a minimum of 2 years for each participant.
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E.5.2 | Secondary end point(s) |
a) All-cause death b) Cardiac death c) Non-fatal recurrent myocardial infarction d) Unscheduled coronary revascularisation e) 18F-NaF uptake localisation to culprit plaque causing the index myocardial infarction f) Territory of subsequent myocardial reinfarction. g) Coronary artery plaque progression by computed tomography coronary angiography. Plaque volume, composition and calcification.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
a-d) time to event during participant follow-up period which will be a minimum of 2 years for each participant e) at 2 years f) time to event during participant follow-up period which will be a minimum of 2 years for each participant g) at 2 years |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
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 | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
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 | No |
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 | 7 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 2 |
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 | No |
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 |
Australia |
United Kingdom |
United States |
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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 | 6 |
E.8.9.1 | In the Member State concerned months | 5 |
E.8.9.1 | In the Member State concerned days | 5 |
E.8.9.2 | In all countries concerned by the trial years | 6 |
E.8.9.2 | In all countries concerned by the trial months | 5 |
E.8.9.2 | In all countries concerned by the trial days | 5 |