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The optimal screening methods for coronary insufficiency, a frequent and pejorative complication in diabetics, are subject to debate, particularly in situations of silent myocardial ischemia. The contemporary strategy consists of pre-selecting asymptomatic patients at very high cardiovascular (CV) risk by performing a coronary calcium score. If this is found to be high >300 AU (Agatston units), the patient is suspected of being at high risk of silent myocardial ischemia (SMI), and the assessment is completed to exclude the presence of coronary artery disease likely to benefit from revascularization.
The complementary evaluation consists in evaluating the myocardial perfusion to judge the perfusion repercussions. The most common examination to date is myocardial scintigraphy, because stress tests are too frequently submaximal in diabetics. However, the reproducibility of scintigraphy is controversial and their sensitivity and specificity are debated in this indication.
This problem is similar in stable symptomatic coronary diabetic patients for whom an indication for functional examinations is justified.
The double-energy double-layer spectral scanner (SDEDC) could now become a relevant tool in this field, since it can combine not only anatomical data (identification of coronary stenosis) but also functional data (myocardial perfusion) during a stress protocol. thanks to the spectral images which make it possible to measure the tissue concentration of intramyocardial iodine downstream of the considered stenosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with CAC ≥ 300 three years ago | Experimental | Patients with CAC ≥ 300 three years ago with the need for repeat screening. Adult asymptomatic diabetic patients whose risk of ischemic complications is considered major in primary prevention due to a calcium score >300 AU and requiring iterative screening for IMS recommended every 3 at 5 years. |
|
| Patients with CAC between 200-299 three years ago | Experimental | Patients with CAC between 200 and 299 three years ago, with the need for a reassessment of their cardiovascular risk. Adult asymptomatic diabetic patients whose risk of ischemic complications is considered major in primary prevention due to a calcium score that has become pathological > 300 AU during the reassessment of their cardiovascular risk. |
|
| Patients with a recent positive scintigraphy (< three months) | Experimental | Patients with a recent positive scintigraphy (< three months) requiring coronary angiography Stable symptomatic diabetic adult patients, suspected of coronary insufficiency in whom the assessment included a positive scintigraphy with indication of coronary angiography in the perspective of revascularization. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dual-energy dual-layer spectral scanner | Device | Realization of dual-energy dual-layer spectral scanner with stress protocol |
|
| Measure | Description | Time Frame |
|---|---|---|
| Identification of tight coronary stenoses justifying coronary angiography | An anomaly considered significant corresponds to:
Reading Committee: Creation of a blind review committee for myocardial SPECT scans and the SDEDC spectral scanner, without knowledge of the coronary angiography data or the other perfusion examination for statistical comparison. | Measured at day 0 |
| Measure | Description | Time Frame |
|---|---|---|
| Identification of tight coronary stenoses justifying a coronary angiography including a measurement of the Fractional Flow Reserve (FFR) | An anomaly considered significant corresponds to:
Reading Committee: Creation of a blind review committee for myocardial SPECT scans and the SDEDC spectral scanner, without knowledge of the coronary angiography data or the other perfusion examination for statistical comparison. |
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Inclusion Criteria:
Exclusion Criteria:
Drug intolerance (adenosine, and/or contrast product used (Iomeron))
Related to iodine injection:
Linked to the injection of adenosine and regadenoson (Cf SPC Adenoscan combination with dipyridamole)
Related to scanner performance
Related to the patient's context
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospices Civils de Lyon | Bron | 69500 | France |
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| ID | Term |
|---|---|
| D023921 | Coronary Stenosis |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Stress protocol with adenosin during dual-energy dual-layer spectral scanner | Drug | Injection of intraveinous adenosin dose 0.78 mg/kg during dual-energy dual-layer spectral scanner |
|
| Measured at day 0 |
| Sensitivity and specificity of the study | Sensitivity and specificity of the study of the perfusion at rest during the SDEDC: 1 to 1 comparison of the data of the SDEC at rest (stenosis and perfusion) with the FFR; with the sensitivities and specificities of SDEDC perfusion to stress; with SPECT scintigraphy under stress. Reading Committee: Creation of a blind review committee for myocardial SPECT scans and the SDEDC spectral scanner, without knowledge of the coronary angiography data or the other perfusion examination for statistical comparison. | Measured at day 0 |
| Proportion of mismatches in diabetics and their predisposing factors | Proportion of mismatches in diabetics and their predisposing factors by identifying tissue perfusion defects (SPECT or SDEDC positive) in patients with a coronary network without angiographically tight stenosis (negative coronarography). Reading Committee: Creation of a blind review committee for myocardial SPECT scans and the SDEDC spectral scanner, without knowledge of the coronary angiography data or the other perfusion examination for statistical comparison. | Measured at day 0 |
| Collection of the subjective assessment of the 2 examinations (SDEDC and myocardial scintigraphy) | Collection of the subjective assessment of the 2 examinations (SDEDC and myocardial scintigraphy) by the patients using a satisfaction questionnaire by telephone call. | Measured at day 1 and 2 |
| D014652 |
| Vascular Diseases |