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| Name | Class |
|---|---|
| Institut National de la Santé Et de la Recherche Médicale, France | OTHER_GOV |
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In this study, multimodal imaging of atherosclerosis and dosage of new circulating biomarkers will be used to compare patients with stable or unstable coronary artery disease
Acute complications of coronary and cerebrovascular atherosclerosis -i.e., acute coronary syndromes (ACS) and strokes - remain the principal cause of death worldwide. Identification of patients at high risk of developing such complications is therefore of utmost importance. Post-MORTEM studies suggest that vulnerable coronary atherosclerotic plaques are characterized by a large, metabolically active, necrotic core, covered by a thin fibrous cap, which may rupture, leading to acute thrombosis, myocardial infarction and, potentially, sudden death. These anatomic features of plaque vulnerability are not visible on standard coronary imaging, such as coronary angiography, but might be recognized using more recent imaging modalities. In addition, new circulating biomarkers of atherosclerosis, particularly biomarkers involved in plaque destabilization, can be measured in peripheral blood and may be used to appreciate overall patient vulnerability.
Design and Methods- In the present study, 2 groups of 44 patients with moderate-to-high risk non-ST elevation ACS or stable coronary artery disease (CAD) will be compared. All the patients will undergo percutaneous coronary intervention of culprit vessels after imaging of the entire coronary tree (culprit and non-culprit lesions) using intravascular ultrasound with radiofrequency data analysis (IVUS-VH). Before discharge, fluorodeoxyglucose positron emission tomography combined with multidetector computed tomography (FDG PET-MDCT) of the carotid arteries and the thoracic aorta, along with MDCT coronary angiography, will be performed and a blood sample will be obtained for subsequent measurements of emerging or new biomarkers.
Objectives -
It's important to underline that this study must be considered as an interventional study. Indeed, in this study patients have many imaging modality : coronary IVUS-VH, MDCT coronary angiography and AORTO-carotid FDG PET-CT while in common practice patients have only FDG PET-CT which is the routinely technique used.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non ST-elevation acute coronary syndrome | Experimental | Coronary intervention using IVUS-VH & FDG PET-MDCT: All the patients will undergo percutaneous coronary intervention of culprit vessels after imaging of the entire coronary tree (culprit and non-culprit lesions) using intravascular ultrasound with radiofrequency data analysis (IVUS-VH). Before discharge, fluorodeoxyglucose positron emission tomography combined with multidetector computed tomography (FDG PET-MDCT) of the carotid arteries and the thoracic aorta, along with MDCT coronary angiography, will be performed and a blood sample will be obtained for subsequent measurements of emerging or new biomarkers. |
|
| Stable coronary artery disease | Experimental | Coronary intervention using IVUS-VH & FDG PET-MDCT: All the patients will undergo percutaneous coronary intervention of culprit vessels after imaging of the entire coronary tree (culprit and non-culprit lesions) using intravascular ultrasound with radiofrequency data analysis (IVUS-VH). Before discharge, fluorodeoxyglucose positron emission tomography combined with multidetector computed tomography (FDG PET-MDCT) of the carotid arteries and the thoracic aorta, along with MDCT coronary angiography, will be performed and a blood sample will be obtained for subsequent measurements of emerging or new biomarkers. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coronary intervention using IVUS-VH & FDG PET-MDCT | Device | All the patients will undergo percutaneous coronary intervention of culprit vessels after imaging of the entire coronary tree (culprit and non-culprit lesions) using intravascular ultrasound with radiofrequency data analysis (IVUS-VH). Before discharge, fluorodeoxyglucose positron emission tomography combined with multidetector computed tomography (FDG PET-MDCT) of the carotid arteries and the thoracic aorta, along with MDCT coronary angiography, will be performed and a blood sample will be obtained for subsequent measurements of emerging or new biomarkers. |
| Measure | Description | Time Frame |
|---|---|---|
| Three imaging modalities are used to compare plaque phenotypes between patients with ACS vs stable CAD. (coronary IVUS-VH, MDCT coronary angiography, AORTO-carotid FDG PET-CT) | Each imaging modality provides a set of quantitative or semi-quantitative measures of plaque vulnerability (eg, necrotic core volume and presence of thin-cap fibroatheroma on IVUS-VH; presence of calcium and positive remodeling on MDCT coronary angiography; and FDG uptake measured by target-to-background on aorto-carotid FDG PET-CT) | Performed within 7 days of inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| New circulating biomarkers | Measured on a blood sample performed within 7 days of inclusion |
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Inclusion Criteria:
First group: Non ST-elevation acute coronary syndrome
Second group: Stable coronary artery disease
Exclusion Criteria:
In both groups
In stable group:
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| Name | Affiliation | Role |
|---|---|---|
| Laurent Feldman, MD, PhD | Assistance Publique - Hôpitaux de Paris | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Département de Cardiologie, Hôpital Bichat, Assistance Publique - Hôpitaux de Paris | Paris | 75018 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22155453 | Derived | Loyau S, Dumont B, Ollivier V, Boulaftali Y, Feldman L, Ajzenberg N, Jandrot-Perrus M. Platelet glycoprotein VI dimerization, an active process inducing receptor competence, is an indicator of platelet reactivity. Arterioscler Thromb Vasc Biol. 2012 Mar;32(3):778-85. doi: 10.1161/ATVBAHA.111.241067. Epub 2011 Dec 8. |
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|
| Coronary intervention using IVUS-VH & FDG PET-MDCT | Device | All the patients will undergo percutaneous coronary intervention of culprit vessels after imaging of the entire coronary tree (culprit and non-culprit lesions) using intravascular ultrasound with radiofrequency data analysis (IVUS-VH). Before discharge, fluorodeoxyglucose positron emission tomography combined with multidetector computed tomography (FDG PET-MDCT) of the carotid arteries and the thoracic aorta, along with MDCT coronary angiography, will be performed and a blood sample will be obtained for subsequent measurements of emerging or new biomarkers. |
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| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D003324 | Coronary Artery Disease |
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
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