Imaging and Biomarkers of Atherosclerosis in Patients With Stable or Unstable Coronary Artery Disease

Coronary Artery Disease Clinical Trial

— BIOCORE-2  

Official title:

BIOmarkers of CORonary Events-2 : Imaging and Biomarkers of Atherosclerosis in Patients With Stable or Unstable Coronary Artery Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01186666
• Other study ID #: P080703
• Status: Completed
• Phase: N/A
• First received: July 12, 2010
• Last updated: February 24, 2015
• Start date: February 2010
• Est. completion date: August 2013

Study information

• Verified date: February 2015
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: August 2013
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Atherosclerosis
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

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.
• 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.

Locations

Country	Name	City	State
France	Département de Cardiologie, Hôpital Bichat, Assistance Publique - Hôpitaux de Paris	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	New circulating biomarkers		Measured on a blood sample performed within 7 days of inclusion	No