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| Name | Class |
|---|---|
| Monaco Scientific center | UNKNOWN |
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Primary prevention of coronary disease and especially its major complication, inaugural myocardial infarction, is based on any prodromal symptoms identification and on risk profile establishment. About 50% of myocardial infarctions are caused by an unstable non-stenosing plaque, asymptomatic before the event since without significant reduction in coronary flow, particularly during a stress test or during stress imaging.
Study purpose is to set up, in medical emergency department, check-up unit and cardiology department, a primary prevention strategy articulated around a routine examination: calcium scoring. The latter makes it possible to categorize patients according to their risk of generating atheromatous plaques and to classify them into several risk levels (groups) according to their score: low (<40th percentile), intermediate (between the 40th percentile and the 65th percentile: group III) or high risk (>65th percentile, group IV). 18F-Na PET scan can mark unstable coronary plaques. For the intermediate risk population who would demonstrate within 6 to 18 months after first calcium score either an increase of percentile of more than 20% or an increase above 20 points of the calcium score and for high risk population, 18F-Na PET scan will be recommended and repeated 6 months later. Secondary prevention treatment will then be administered in the event of an abnormal examination.
The purpose of this protocol is to determine the frequency and the mapping of unstable coronary plaques highlighted by 18F-Na PET in patients at intermediate and high risk, as well as their evolution under treatment.
Aside from traditional risk factors collection and related biological assessments, risk establishment is based on calcium score, a simple non-injected and very little irradiating scanner which measures coronary calcifications, stigmata of healed atheroma plaques and, as a rule, non-evolving. Calcium score, which is interpreted according to age, sex and ethnicity, therefore makes it possible to assign a percentile within the distribution of all the patients and to classify patients in:
Study assumptions are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients of groups III and IV | Experimental | Patients who are categorized after calcium score determination as presenting an intermediate risk to produce atheromatous plaques (group III : between the 40th percentile and the 65th percentile) or presenting a high risk to produce such plaques (group IV: >65th percentile). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 18F-Na PET Scan | Diagnostic Test | For the intermediate risk population who would demonstrate within 6 to 18 months after first calcium score either an increase of percentile of more than 20% or an increase above 20 points of the calcium score and for high risk population, 18F-Na PET scan will be recommended and repeated 6 months later. Secondary prevention treatment will then be administered in the event of an abnormal examination. |
| Measure | Description | Time Frame |
|---|---|---|
| Unstable coronary plaque evolution description through calcium score variation | Unstable coronary plaque evolution will be described through calcium score variation calculation. | 8 months |
| Unstable coronary plaque evolution description through coro-scanner plaque size variations | Unstable coronary plaque evolution will be described through coro-scanner plaque size variations measurement | 8 months |
| Unstable coronary plaque evolution description through coro-scanner plaque density variations | Unstable coronary plaque evolution will be described through coro-scanner plaque density variations measurement | 8 months |
| Unstable coronary plaque evolution description through coro-scanner morphological aspect variations | Unstable coronary plaque evolution will be described through coro-scanner morphological aspect variations | 8 months |
| Unstable coronary plaque evolution description through coro-scanner variations in terms of stenosis diameter | Unstable coronary plaque evolution will be described through coro-scanner variations in terms of stenosis diameter | 8 months |
| Unstable coronary plaque evolution description through 18F-Na PET scan target binding variations | Unstable coronary plaque evolution will be described through 18F-Na PET scan binding variations (number of targets). | 8 months |
| Unstable coronary plaque evolution description through 18F-Na PET scan binding intensity variations |
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness of primary cardiovascular prevention strategy initiation by the care team | Evaluation at study end of the number of patients having entered the monitoring system, the number of patients with signs of coronary involvement and percentage of patients with coronary progression criteria. | 24 months |
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Inclusion Criteria:
Patient with no coronary history presenting to the emergency room, to the assessment unit or having consulted in the cardiology department for suspicious chest pain that does not allow an acute coronary syndrome or angina to be excluded and:
Age above or equal to 18 and strictly below 80 years old
Having given informed consent
Exclusion Criteria:
Pregnant woman
Patient with cognitive disorders
Claustrophobic patient, or refusing radiological examinations
Patient refusing cardiological follow-up and/or treatment of his risk factors or refusing to participate in the study
Patient with contraindications or intolerances to HMG-CoA reductase inhibitors (statins) and/or Ezetimibe
Patient with liver failure
Patient with myopathy or with a history of (rhabdo)myolysis
Marked arrhythmia and in particular supraventricular or ventricular hyperexcitability, or chronic or paroxysmal atrial fibrillation not controlled by antiarrhythmic treatment
Patients with a history of sternotomy or valve replacement or metallic intracardiac probes, generators of scanner artefacts
Calcium score corresponding to the percentiles of groups I and II
For patients in groups III and IV:
Person participating in another biomedical research
Person under judicial protection (guardianship, curatorship...)
Person deprived of liberty by a judicial or administrative decision.
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| Name | Affiliation | Role |
|---|---|---|
| Yann-Erick CLAESSENS, MD-PhD | Centre Hospitalier Princesse Grace | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Princesse Grace | Monaco | 98000 | Monaco |
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Unstable coronary plaque evolution will be described through 18F-Na PET scan binding variations (SUVmax for each target). |
| 8 months |
| Comparison of study cohort symptoms evolution to the symptoms evolution of an historical local cohort with comparable symptomatology which motivated the implementation of a "secondary prevention type" treatment |
The number of persistent symptoms increasing and leading to the prescription of new tests (based on clinical management and good practices) and the number of symptoms having completely disappeared will be compared between the study cohort and the local historical one. |
| 24 months |
| Compare, between study cohort and historical cohort, the rate of occurrence of cardiovascular events of interest | Number of following cardiovascular events will be presented:
| 24 months |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D058226 | Plaque, Atherosclerotic |
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
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