NCT01186666

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
85

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 12, 2010

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 23, 2010

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

February 25, 2015

Status Verified

February 1, 2015

Enrollment Period

2.4 years

First QC Date

July 12, 2010

Last Update Submit

February 24, 2015

Conditions

AtherosclerosisCoronary Artery DiseaseAcute Coronary Syndrome

Keywords

AtherosclerosisVulnerable plaqueIntravascular ultrasoundVirtual histologyFluorodeoxyglucosePositron emission tomographyMultidetector computed tomography

Outcome Measures

Primary Outcomes (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)

    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

Secondary Outcomes (1)

  • New circulating biomarkers

    Measured on a blood sample performed within 7 days of inclusion

Study Arms (2)

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.

Device: Coronary intervention using IVUS-VH & FDG PET-MDCT

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.

Device: Coronary intervention using IVUS-VH & FDG PET-MDCT

Interventions

Coronary intervention using IVUS-VH & FDG PET-MDCTDEVICE

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.

Non ST-elevation acute coronary syndrome

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Paris, 75018, France

Location

Related Publications (1)

  • 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.

    PMID: 22155453DERIVED

MeSH Terms

Conditions

AtherosclerosisCoronary Artery DiseaseAcute Coronary Syndrome

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesCoronary DiseaseMyocardial IschemiaHeart Diseases

Study Officials

  • Laurent Feldman, MD, PhD

    Assistance Publique - Hôpitaux de Paris

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 12, 2010

First Posted

August 23, 2010

Study Start

February 1, 2010

Primary Completion

July 1, 2012

Study Completion

August 1, 2013

Last Updated

February 25, 2015

Record last verified: 2015-02

Locations

FR(1)