Imaging and Biomarkers of Atherosclerosis in Patients With Stable or Unstable Coronary Artery Disease (BIOCORE-2)

Study Description

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Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Atherosclerosis; Coronary Artery Disease; Acute Coronary Syndrome	Device: Coronary intervention using IVUS-VH & FDG PET-MDCT	Not Applicable

Detailed Description:

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 -

1. The primary objective is to compare plaque phenotypes between patients with ACS vs stable CAD. For each imaging modality (coronary IVUS-VH, MDCT coronary angiography, AORTO-carotid FDG PET-CT) comparisons will be performed on a per-lesion and per-patient basis.
2. Secondary objectives include: i) An evaluation of the accuracy of each plaque imaging modality and biomarkers for diagnosis of unstable CAD; ii) A comparison of the diagnostic performance of each plaque imaging modality and biomarkers for diagnosis of unstable CAD; iii) A comparison of coronary plaque phenotype between culprit and non-culprit lesions (using IVUS-VH and MDCT coronary angiography); and iv) An exploratory feasibility study of PET-CT imaging of coronary artery atherosclerotic plaques.

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	85 participants
Allocation:	Non-Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Diagnostic
Official Title:	BIOmarkers of CORonary Events-2 : Imaging and Biomarkers of Atherosclerosis in Patients With Stable or Unstable Coronary Artery Disease
Study Start Date :	February 2010
Actual Primary Completion Date :	July 2012
Actual Study Completion Date :	August 2013

Arms and Interventions

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Arm	Intervention/treatment
Experimental: Non ST-elevation acute coronary syndrome; 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.	Device: 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.
Experimental: Stable coronary artery disease; 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.	Device: 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.

Outcome Measures

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Primary Outcome Measures :

1. 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) [ Time Frame: Performed within 7 days of inclusion ]
   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)

Secondary Outcome Measures :

1. New circulating biomarkers [ Time Frame: Measured on a blood sample performed within 7 days of inclusion ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

First group: Non ST-elevation acute coronary syndrome

• Symptoms compatible with acute myocardial ischaemia
• Presence of either significant ST-T changes without persistent ST elevation or positive troponin I
• And successful stenting of culprit, de novo coronary stenosis located on native coronary arteries

Second group: Stable coronary artery disease

• Stable angina or silent myocardial ischaemia (documented by a positive stress test)
• And successful stenting of culprit, de novo coronary stenosis located on native coronary arteries

Exclusion Criteria:

In both groups

• Absence of percutaneous coronary angioplasty
• IVUS imaging not feasible
• Heart failure (≥NYHA class 2)
• Severe, persistent arrhythmia
• Renal failure (GFR < 60 ml/min using MDRD formula)
• History of autoimmune or inflammatory disease, recent sepsis (< 1 month), neoplasm
• Females without contraception (if at childbearing age)
• Pregnant of child feeding females
• Homeless
• Patients with no health coverage
• Refusal to sing informed consent
• Allergy to FDG or iodinated contrast media

In stable group:

• History of acute coronary syndrome
• History of stroke

Contacts and Locations

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Locations

France
Département de Cardiologie, Hôpital Bichat, Assistance Publique - Hôpitaux de Paris
Paris, France, 75018

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Institut National de la Santé Et de la Recherche Médicale, France

Investigators

Study Director:	Laurent Feldman, MD, PhD	Assistance Publique - Hôpitaux de Paris

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:	NCT01186666 History of Changes
Other Study ID Numbers:	P080703
First Posted:	August 23, 2010
Last Update Posted:	February 25, 2015
Last Verified:	February 2015

Keywords provided by Assistance Publique - Hôpitaux de Paris:

Atherosclerosis; Vulnerable plaque; Intravascular ultrasound; Virtual histology	Fluorodeoxyglucose; Positron emission tomography; Multidetector computed tomography

Additional relevant MeSH terms:

Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Atherosclerosis; Acute Coronary Syndrome; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Glucuronyl glucosamine glycan sulfate; Deoxyglucose; Fluorodeoxyglucose F18	Anticoagulants; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Lipid Regulating Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Hypoglycemic Agents; Physiological Effects of Drugs; Radiopharmaceuticals; Antiviral Agents; Anti-Infective Agents