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The purpose of SCADIAB is to assess the real-life efficiency of systematic screening for ischemic heart disease in T2DM patients at very high cardiovascular risk, without known coronary heart disease, from the databases of the National Health Data System (SNDS).
Type 2 diabetes mellitus (T2DM) is associated with an increased risk of cardiovascular and overall mortality. Cardiovascular disease is the leading cause of death, primarily ischemic heart disease, which is often early and can occur in asymptomatic diabetic patients, hence the potential benefit of routine screening to improve their cardiovascular prognosis.
There is a notable disparity between the recommendations of the french High Authority of Health (HAS) and those of learned societies. The HAS does not recommend routine screening for silent ischemic heart disease in all asymptomatic T2DM patients without known coronary heart disease, apart from a resting electrocardiogram (ECG). Functional cardiovascular examinations should be reserved for situations of high cardiovascular risk, particularly the presence of history, clinical symptoms or ECG abnormalities in favor of cardiovascular disease. On the other hand, the main learned societies of diabetology and cardiology recommend systematic screening for silent ischemic heart disease in a larger T2DM population (age> 60 years, duration of diabetes> 10 years and at least 2 cardiovascular risk factors). In terms of current clinical practice, a majority of physicians prescribe screening for silent ischemic heart disease in diabetic patients by functional examinations (stress test, myocardial tomoscintigraphy coupled with a stress test, stress echocardiography) . The investigators carried out two surveys with fellow cardiologists and diabetologists in Bordeaux and at the national level which confirm this frequent practice of screening.
The level of scientific evidence currently seems sufficient not to recommend systematic screening for silent ischemic heart disease in all diabetic patients. Four main randomized and controlled studies have not shown any benefit from this screening in terms of reducing major cardiovascular events in all T2DM patients. However, doubt remains in T2DM patients at very high cardiovascular risk, who may benefit from this strategy, but in whom no studies have been performed to date.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | The experimental group "systematic screening for ischemic heart disease" will be identified during the screening period by performing at least one systematic screening examination, regardless of the frequency, for ischemic heart disease in patients. diabetics at very high cardiovascular risk, without known coronary heart disease, by at least one non-invasive functional cardiovascular exploration outside the resting ECG. |
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| Control | The control group "Absence of systematic screening for ischemic heart disease" will be identified during the pre-selection period by the absence of a non-invasive functional cardiovascular exploration (examinations mentioned above) in T2D with very high cardiovascular risk, with no known coronary heart disease, apart from performing a resting ECG |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Systematic screening for ischemic heart disease in type 2 diabetic patients | Other | Systematic screening for ischemic heart disease in type 2 diabetic patients at very high cardiovascular risk, without known coronary heart disease. |
| Measure | Description | Time Frame |
|---|---|---|
| Cost-effectiveness analysis of routine screening for ischemic heart disease in T2DM patients | The cost-effectiveness analysis is based on the differential cost per year of life gained at 4 years from the point of view of Health Insurance (SNDS). | 4 years after inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| Cost/consequence analysis for ischemic heart disease in T2DM patients. | Direct costs (€) observed over 4 years for each strategy evaluated (screening and no screening ischemic heart disease). Based on SNDS analysis. | 4 years after inclusion |
| Budget impact analysis for Health Insurance of the most efficient strategy |
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Inclusion Criteria:
Exclusion Criteria:
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Among the 3.3 million people treated pharmacologically for diabetes mellitus in France, at least 3 million would be T2DM. It can be assumed that at least 2.4 million are free from coronary heart disease. This survey also shows that arterial hypertension and dyslipidemia (the two main cardiovascular risk factors) are present respectively in 58% and 57% of T2DM patients, and renal, neuropathic, or retinal complications are present respectively in 10%, 11% and 8% of them. Therefore, it can be estimated that at least 90,000 T2DM patients would be eligible (at least 2 cardiovascular risk factors and one other vascular disease) to be included in the study.
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| Name | Affiliation | Role |
|---|---|---|
| Julien BEZIN, Dr | University Hospital, Bordeaux | Study Chair |
| Antoine BENARD, Dr | USMR | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Haut-Leveque | Pessac | 33600 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33714278 | Derived | Mohammedi K, Preaubert N, Cariou T, Rigalleau V, Foussard N, Piazza L, Bairras-Martin C, Couffinhal T, Bezin J, Benard A. Cost-effectiveness of screening of coronary artery disease in patients with type 2 DIABetes at a very high cardiovascular risk (SCADIAB study) rational and design. Cardiovasc Diabetol. 2021 Mar 13;20(1):63. doi: 10.1186/s12933-021-01253-2. |
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Net benefit for Health Insurance (€) from promoting the most efficient strategy: screening or no screening ischemic heart disease. |
| 4 years after inclusion |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D017202 | Myocardial Ischemia |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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