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| Name | Class |
|---|---|
| Novo Nordisk A/S | INDUSTRY |
| CEBIMER | UNKNOWN |
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There are currently only few data on the coronary artery calcium score in patient with diabetes in France, and the diagnostic and therapeutic attitudes towards a high coronary artery calcium score are not standardized and depend on clinical practices, which may vary from one center to another. The proposed multicenter prospective study would provide a better understanding of the epidemiological particularities of the coronary artery calcium score in French diabetics, refine the indications for better performance of the examination, and compare attitudes when this score is high.
The prevalence of coronary heart disease in patient with diabetes varies according to the patient's age, the duration of the diabetes, the coexistence of other heart disease risk factors, but also the type of diagnostic used to detect it. In addition, clinical symptoms are often lacking in diabetic patients.
The latest recommendations from the European Society of Cardiology in 2018 propose a graduation of cardiovascular risk into 3 categories according to the presence of cardiovascular disease, other target organ damage, the duration of diabetes and the coexistence of other heart disease risk factors.
The use of imaging can be considered to refine the cardiovascular risk stratification , such as detection of carotid plaque (class IIa), coronary artery calcium score (class IIb) or even the coronary scanner or ischemia tests (class IIb ). In a much more pragmatic and operational way, the French Society of Cardiology and the Francophone Society of Diabetology very recently published a consensus document, proposing a cardiovascular risk stratification based on clinical elements, the existence of other cardiovascular risk factors and target organ damage risk factors, and the use of the coronary artery calcium score to stratify in particular patients qualified as high risk.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Coronary artery calcium score evaluation | Patients with diabetes and having a CT scan for evaluation of their coronary artery calcium score will be consecutively include. The indication of the scanner is at the choice of the clinician (usually cardiologist and/or diabetologist), in compliance with the recommendations |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coronary artery calcium score evaluation | Diagnostic Test | The evaluation of the coronary artery calcium score will be performed with chest CT scan |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportions of diabetic patients with high coronary artery calcium score | Number of patient with diabetes having a coronary artery calcium score higher than 400 | day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients having a coronary exploration | Number of patient with high coronary artery calcium (>400) score having a coronary exploration compared with patient with low coronary artery calcium score (<400) | 6 months |
| Proportion of patients having a myocardial revascularization |
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Inclusion Criteria:
Exclusion Criteria:
Participation in another biomedical research protocol is permitted
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The centers participating in this study undertake to consecutively include all diabetic patients meeting the selection criteria and having a CT scan for evaluation of coronary artery calcium score. The indication for the scanner is at the choice of the clinician (usually cardiologist and/or diabetologist), in accordance with the recommendations. This is a standard practice study. The patient will be informed of the possibility to participate to the study and his consent will be obtained by the cardiologist/diabetologist when it will be decided to perform a chest CT scan to estimate the coronary artery calcium score. All scanner prescriptions will be carried out according to clinical indications in standard practice.
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| Name | Affiliation | Role |
|---|---|---|
| Victor ABOYANS, MD | University Hospital, Limoges | Principal Investigator |
| Tessa BERGOT | Société Française de la Cardiologie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Bordeaux | Bordeaux | 33000 | France | |||
| CHU de Limoges |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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Number of patient with high coronary artery calcium score (>400) having a myocardial revascularization compared with patient with low coronary artery calcium score (<400) |
| 3 months |
| Description of adverse events regarding to the coronary artery calcium score | Calculation of number and type of cardiovascular adverse event within patient with high coronary artery calcium score (>400) or low coronary artery calcium score (<400) | 6 months / 12 months / 18 months / 24 months / 30 months / 36 months / 42 months / 48 months |
| Limoges |
| 87000 |
| France |
| CHU de Nice | Nice | 06000 | France |
| Hôpital Lariboisière, APHP | Paris | 75010 | France |
| Hopital Saint Antoine | Paris | 75012 | France |
| CHU de Poitiers | Poitiers | 86000 | France |
| CHU de la Réunion | Saint-Denis | 97400 | France |
| Centre de Cardiologie de Thionville | Thionville | 57100 | France |
| CHU de Tours | Tours | 37000 | France |