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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-A00453-46 | Registry Identifier | National number |
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| Name | Class |
|---|---|
| France 2030 program | UNKNOWN |
| European Union | OTHER |
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The goal of this study (interventional clinical research not involving a health product) is to assess the prevalence of subclinical coronary atherosclerosis diagnosed by coronary CT angiography in heart failure patients in primary prevention, across different levels of cardiovascular risk defined by coronary artery calcium (CAC) score percentiles (based on data from the MESA study): low risk (≤25th percentile for age, sex, and ethnicity), intermediate risk (25th < CAC ≤ 75th percentile), and high risk (>75th percentile). The Patients will attend an on-site visit at inclusion (and must undergo a coronary CT angiography within 6 months following this visit), will be contacted by phone at 1 year and 2 years, and will return for an on-site visit at 30 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm | Other | Visit 1: Inclusion Visit: Verification of eligibility criteria. Consent form signing, collection of clinical information, and completion of questionnaires. Fasting blood draw for biological analyses and biobanking. Collection of urine and stool samples (optional). POpmeter (optional), Fibroscan (optional), completion of the CONSTANCES and SF36 questionnaires. Visit 2 (30 months): Collection of the CAC score result (dated less than 6 months prior). Collection of clinical information and completion of questionnaires. Fasting blood draw for biological analyses and biobanking. Collection of urine and stool samples (optional). pOpmeter (optional), Fibroscan (optional), completion of the CONSTANCES and SF36 questionnaires. Major cardiovascular events will be collected from patients during telephone calls at 1 and 2 years, and during the 30-month visit. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coronary CT scan with CAC score measurement | Other | Coronary CT scan with CAC score measurement (on the same day or within 6 months after the inclusion visit). |
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| Measure | Description | Time Frame |
|---|---|---|
| Presence of subclinical coronary atherosclerosis | The criterion defining the presence of subclinical coronary atherosclerosis is the presence of at least one coronary stenosis greater than 50% in a main artery on coronary CT angiography | At the time of performing the coronary CT scan |
| Measure | Description | Time Frame |
|---|---|---|
| Identification of factors associated with the presence or absence of subclinical coronary atherosclerosis (coronary stenosis > 50% on coronary CT scan). | The anthropometric data collected as part of the current study will be comparable to the data collected as part of the SAFIR study | 30 months |
| Identification of factors associated with the presence or absence of subclinical coronary atherosclerosis (coronary stenosis > 50% on coronary CT scan). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bertrand CARIOU, Pr | Contact | +33 2 53 48 27 10 | bertrand.cariou@chu-nantes.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Dijon Bourgogne | Recruiting | Dijon | France |
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Pathophysiology study
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The clinic data collected as part of the current study will be comparable to the data collected as part of the SAFIR study |
| 30 months |
| Identification of factors associated with the presence or absence of subclinical coronary atherosclerosis (coronary stenosis > 50% on coronary CT scan). | The drug treatments collected as part of the current study will be comparable to the data collected as part of the SAFIR study. | 30 months |
| Identification of factors associated with the presence or absence of subclinical coronary atherosclerosis (coronary stenosis > 50% on coronary CT scan). | The genetic data collected as part of the current study will be comparable to the data collected as part of the SAFIR study. | 30 months |
| Identification of factors associated with the presence or absence of subclinical coronary atherosclerosis (coronary stenosis > 50% on coronary CT scan). | The biological data collected as part of the current study will be comparable to the data collected as part of the SAFIR study. | 30 months |
| Identification of factors associated with the presence or absence of subclinical coronary atherosclerosis (coronary stenosis > 50% on coronary CT scan). | Arterial Doppler ultrasound of the carotid arteries and lower limbs as part of the current study will be comparable to the data collected as part of the SAFIR study. | 30 months |
| Identification of factors associated with the presence or absence of subclinical coronary atherosclerosis (coronary stenosis > 50% on coronary CT scan). | Pulse wave velocity measured by the pOpmeter as part of the current study will be comparable to the data collected as part of the SAFIR study. | 30 months |
| Identification of factors associated with the presence or absence of subclinical coronary atherosclerosis (coronary stenosis > 50% on coronary CT scan). | Hepatic steatosis as part of the current study will be comparable to the data collected as part of the SAFIR study. | 30 months |
| Identification of factors associated with the presence or absence of subclinical coronary atherosclerosis (coronary stenosis > 50% on coronary CT scan). | Hepatic fibrosis as part of the current study will be comparable to the data collected as part of the SAFIR study. | 30 months |
| Identification of factors associated with the presence or absence of subclinical coronary atherosclerosis (coronary stenosis > 50% on coronary CT scan). | Nutritional data as part of the current study will be comparable to the data collected as part of the SAFIR study. | 30 months |
| Identification of factors associated with the presence or absence of subclinical coronary atherosclerosis (coronary stenosis > 50% on coronary CT scan). | Physical activity as part of the current study will be comparable to the data collected as part of the SAFIR study. | 30 months |
| Identification of factors associated with the presence or absence of subclinical coronary atherosclerosis (coronary stenosis > 50% on coronary CT scan). | Quality of life as part of the current study will be comparable to the data collected as part of the SAFIR study. | 30 months |
| Identification of factors associated with a coronary calcium score less than or equal to the 25th percentile | The anthropometric data collected as part of the current study will be comparable to the data collected as part of the SAFIR study | 30 months |
| Identification of factors associated with a coronary calcium score less than or equal to the 25th percentile | The clinic data collected as part of the current study will be comparable to the data collected as part of the SAFIR study | 30 months |
| Identification of factors associated with a coronary calcium score less than or equal to the 25th percentile | The drug treatments collected as part of the current study will be comparable to the data collected as part of the SAFIR study. | 30 months |
| Identification of factors associated with a coronary calcium score less than or equal to the 25th percentile | The genetic data collected as part of the current study will be comparable to the data collected as part of the SAFIR study. | 30 months |
| Identification of factors associated with a coronary calcium score less than or equal to the 25th percentile | The biological data collected as part of the current study will be comparable to the data collected as part of the SAFIR study. | 30 months |
| Identification of factors associated with a coronary calcium score less than or equal to the 25th percentile | Arterial Doppler ultrasound of the carotid arteries and lower limbs as part of the current study will be comparable to the data collected as part of the SAFIR study. | 30 months |
| Identification of factors associated with a coronary calcium score less than or equal to the 25th percentile | Pulse wave velocity measured by the pOpmeter as part of the current study will be comparable to the data collected as part of the SAFIR study. | 30 months |
| Identification of factors associated with a coronary calcium score less than or equal to the 25th percentile | Hepatic steatosis as part of the current study will be comparable to the data collected as part of the SAFIR study. | 30 months |
| Identification of factors associated with a coronary calcium score less than or equal to the 25th percentile | Hepatic fibrosis as part of the current study will be comparable to the data collected as part of the SAFIR study. | 30 months |
| Identification of factors associated with a coronary calcium score less than or equal to the 25th percentile | Nutritional data as part of the current study will be comparable to the data collected as part of the SAFIR study. | 30 months |
| Identification of factors associated with a coronary calcium score less than or equal to the 25th percentile | Physical activity as part of the current study will be comparable to the data collected as part of the SAFIR study. | 30 months |
| Identification of factors associated with a coronary calcium score less than or equal to the 25th percentile | Quality of life as part of the current study will be comparable to the data collected as part of the SAFIR study. | 30 months |
| Study of the association between the characteristics of coronary atheroma plaque on coronary CT and major cardiovascular events at 30 months. | Semi-quantitative visual quantification of coronary stenoses on CT coronary angiography according to the CAD-RADS v2.0 classification and visual characterization of high-risk plaque features (vulnerability). | 30 months |
| Study of the association between the characteristics of coronary atheroma plaque on coronary CT and major cardiovascular events at 30 months. | Quantification of total coronary atherosclerotic plaque, calcified and non-calcified, and by artery | 30 months |
| Study of the association between the presence of subclinical atherosclerosis (coronary stenosis > 50% on CT coronary angiography) and major cardiovascular events at 30 months | Assess the association between the presence of significant coronary stenosis (>50% on a major artery) on coronary CT and the following major cardiovascular events:
| 30 months |
| Study of the association between the percentile of the coronary calcium score and major cardiovascular events and overall mortality at 30 months | Assess the occurrence of major cardiovascular events and mortality according to the percentile of the coronary calcium score. | 30 months |
| Study of the association between arterial stiffness and major cardiovascular events and overall mortality at 30 months. | Assess the occurrence of major cardiovascular events and mortality according to the measurement of arterial stiffness evaluated by pulse wave velocity measured with the pOpmeter | 30 months |
| Study of the association between the presence of hepatic steatosis and major cardiovascular events and overall mortality at 30 months | Evaluer la survenue des événements cardiovasculaires majeurs et la mortalité en fonction de la stéatose hépatique | 30 months |
| Study of the association between the presence of liver fibrosis and major cardiovascular events and all-cause mortality at 30 months | Assess the occurrence of major cardiovascular events and mortality according to the presence of liver fibrosis | 30 months |
| CHRU Lille | Not yet recruiting | Lille | France |
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| Hospices Civils de Lyon | Recruiting | Lyon | France |
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| Hôpital de la Conception, AP-HM | Not yet recruiting | Marseille | France |
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| CHU Nantes | Recruiting | Nantes | France |
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| Hôpital de la Pitié-Salpêtrière, AP-HP | Recruiting | Paris | France |
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| Hôpital Saint-Antoine, AP-HP | Recruiting | Paris | France |
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| CHU Rennes | Recruiting | Rennes | France |
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| CHU Strasbourg | Recruiting | Strasbourg | France |
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| ID | Term |
|---|---|
| D006938 | Hyperlipoproteinemia Type II |
| D050197 | Atherosclerosis |
| ID | Term |
|---|---|
| D008052 | Lipid Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006951 | Hyperlipoproteinemias |
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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