AtherosclerosisBIOCORE-2NCT01186666
Imaging and Biomarkers of Atherosclerosis in Patients With Stable or Unstable Coronary Artery Disease
A study testing Coronary intervention using IVUS-VH & FDG PET-MDCT in people with Atherosclerosis and Coronary Artery Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atherosclerosis, Coronary Artery Disease, Acute Coronary Syndrome
- What is being tested?
- Coronary intervention using IVUS-VH & FDG PET-MDCT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2010to Aug 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Département de Cardiologie, Hôpital Bichat, Assistance Publique - Hôpitaux de Paris
Paris, 75018
About this study
Official title: BIOmarkers of CORonary Events-2 : Imaging and Biomarkers of Atherosclerosis in Patients With Stable or Unstable Coronary Artery Disease
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
Read the 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 -
- 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.
- 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.
- Being tested
- Coronary intervention using IVUS-VH & FDG PET-MDCT
- Keywords
- Atherosclerosis, Vulnerable plaque, Intravascular ultrasound, Virtual histology, Fluorodeoxyglucose, Positron emission tomography, Multidetector computed tomography
- Medical subject headings
- Atherosclerosis, Coronary Artery Disease, Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Coronary intervention using IVUS-VH & FDG PET-MDCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Performed within 7 days of inclusion
Secondary outcomes (1)
New circulating biomarkers
Measured: Measured on a blood sample performed within 7 days of inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2010 (estimated)
- Study startFeb 2010
- Primary completionJul 2012
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AtherosclerosisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurent Feldman, MD, PhD, Study director, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01186666
- Sponsor's protocol ID
- P080703
- Acronym
- BIOCORE-2
- Status last verified
- Feb 2015
- First submitted
- 12 Jul 2010
- Last updated
- 25 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22155453
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BIOmarkers of CORonary Events-2 : Imaging and Biomarkers of Atherosclerosis in Patients With Stable or Unstable Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT01186666
- Acronym / sponsor ID
- BIOCORE-2 / P080703
- Keywords
- Atherosclerosis, Vulnerable plaque, Intravascular ultrasound, Virtual histology, Fluorodeoxyglucose, Positron emission tomography, Multidetector computed tomography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- Feb 2010
- Primary completion
- Jul 2012 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 23 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 -
- 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.
- 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
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non ST-elevation acute coronary syndrome | Experimental | Device: Coronary intervention using IVUS-VH & FDG PET-MDCTCoronary 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 | Device: Coronary intervention using IVUS-VH & FDG PET-MDCTCoronary 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (16 listed)
- In both groups
- Absence of percutaneous coronary angioplasty
- IVUS imaging not feasible
- Heart failure (≥NYHA class 2)
- Severe, persistent arrhythmia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coronary intervention using IVUS-VH & FDG PET-MDCTAll 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 | Non ST-elevation acute coronary syndrome |
| Coronary intervention using IVUS-VH & FDG PET-MDCTAll 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 | Stable coronary artery disease |
Primary outcome
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)
1 secondary outcome
New circulating biomarkers
Time frame: Measured on a blood sample performed within 7 days of inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2015.
- Derived from this study: PubMed 22155453Loyau 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laurent Feldman, MD, PhD study director
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coronary intervention using IVUS-VH & FDG PET-MDCT in people with Atherosclerosis and Coronary Artery Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01186666, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2015.