Imaging of Vulnerable Plaques in Coronary Artery Disease by Multidetector Computed Tomography
NCT ID: NCT00482651
Last Updated: 2012-01-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2007-11-30
2012-01-31
Brief Summary
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The great majority of coronary plaques will remain quiescent, at least from a clinical point of view.
Acute coronary syndrome is primarily precipitated by a ruptured plaque. The precipitating factor or condition may be found outside rather than inside the plaque.
The challenge is to find the plaque(s) destined for the next thrombus-mediated heart attack(s), treat, and thus avoid the heart attack(s). Identification of vulnerable plaques has become a key issue. The natural history of individual plaques (risk of thrombosis) is unknown and needs to be established.
Multidetector computed tomography (MDCT) can provide angiography and imaging of the vessel wall (detection, quantification and characterization of plaques).
The intention of this project is to evaluate the accuracy of coronary MDCT in identifying and differentiating the morphology of coronary atherosclerotic plaques.
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Detailed Description
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Post-mortem and clinical observations indicate that patients with acute coronary syndromes often have many ruptured and/or active plaques in their coronary arteries.
The challenge is to find the plaque(s) destined for the next thrombus-mediated heart attack(s), treat, and thus avoid the heart attack(s). Identification of vulnerable plaques have become a key issue. The natural history of individual plaques (risk of thrombosis) is unknown and needs to be established. Multidetector computed tomography (MDCT) can provide angiography and imaging of the vessel wall.
Hypothesis:
It is by CT-scanning possible to 1a) identify and differentiate the morphology of coronary atherosclerotic plaques.
1b) identify vulnerable plaques.
Materials and methods:
1. Development of an MDCT scan protocol for accurate assessment of coronary artery plaque composition by ex vivo examination of human coronary arteries from the Institute of Forensic Medicine, University of Aarhus. Scan protocols parameters and intravascular contrast material will be varied to optimize accurate assessment of coronary plaque composition. MDCT will be compared to histopathology.
2. A cross-sectional study with clinical application of the efficiency parameters defined in sub-study 1. Forty consecutive patients with non ST-elevation myocardial infarction/unstable angina, and 80 consecutive patients with stable angina will be recruited and investigated with MDCT followed by CAG with IVUS/virtual histology.
3. A prospective, longitudinal study. After a period of 12 months all patients from sub-study 2 will be re-investigated.
4. Before the cross-sectional study a small pilot-study will be performed. Ten patients with non ST-elevation myocardial infarction/unstable angina will undergo MDCT and CAG with IVUS/virtual histology. These patients will after one months undergo another MDCT. This is done to make sure that it is possible to perform the planned longitudinal study.
Research plan:
1. Development of an MDCT scan protocol for accurate assessment of coronary artery plaque composition.
2. Clinical application of the MDCT scan protocol for in vivo differentiation of coronary artery plaque morphology. Morphologic findings will be categorized and compared with IVUS/virtual histology for confirmation.
3. Re-evaluation of plaque density and morphology one year after inclusion by a second in vivo contrast-enhanced MDCT-scanning to define which morphological plaque categories are at risk of progression.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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UAP, SAP
Multidetector computed tomography scanning
contrast Multidetector CT-scanning
Coronary angiography (CAG)
CAG and if necessary PCI. Included patients are already assigned for CAG
Intravascular ultrasound
During CAG Intravascular Ultrasound will be performed in the three coronary arteries
Blood sample
a blood sample at baseline after 3 months and at the end of the follow up (after 12 months)
Interventions
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Multidetector computed tomography scanning
contrast Multidetector CT-scanning
Coronary angiography (CAG)
CAG and if necessary PCI. Included patients are already assigned for CAG
Intravascular ultrasound
During CAG Intravascular Ultrasound will be performed in the three coronary arteries
Blood sample
a blood sample at baseline after 3 months and at the end of the follow up (after 12 months)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Danish Research Agency
OTHER
Philips Medical Systems
INDUSTRY
Danish Heart Foundation
OTHER
University of Aarhus
OTHER
Responsible Party
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Principal Investigators
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Hans Erik Boetker, MD,PhD,DMSc
Role: STUDY_DIRECTOR
Aarhus University Hospital
Locations
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Department of Cardiology, Aarhus University hospital, Skejby
Aarhus N, , Denmark
Countries
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Other Identifiers
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MDCT2403
Identifier Type: -
Identifier Source: org_study_id
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