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Sponsors and Collaborators: |
University of Aarhus Danish Research Agency Philips Medical Systems Danish Heart Foundation |
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Information provided by: | University of Aarhus |
ClinicalTrials.gov Identifier: | NCT00482651 |
Atherosclerosis is a chronic and multifocal immunoinflammatory, fibroproliferative disease of medium-sized and large arteries driven by lipid. Atherosclerosis is rarely fatal unless thrombosis supervene, causing an acute coronary syndrome. Therefore, for event-free survival, the vital question is not why atherosclerosis develops but rather why atherosclerosis, after years after indolent growth, suddenly becomes complicated with luminal thrombosis.
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.
Condition | Intervention |
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Atherosclerosis |
Radiation: Multidetector computed tomography scanning Procedure: Coronary angiography (CAG) Procedure: Intravascular ultrasound Procedure: Blood sample |
Study Type: | Interventional |
Study Design: | Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment |
Official Title: | Imaging of Vulnerable Plaques in Coronary Artery Disease by Multidetector Computed Tomography |
Estimated Enrollment: | 80 |
Study Start Date: | November 2007 |
Estimated Study Completion Date: | June 2010 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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UAP, SAP: Experimental |
Radiation: Multidetector computed tomography scanning
contrast Multidetector CT-scanning
Procedure: Coronary angiography (CAG)
CAG and if necessary PCI. Included patients are already assigned for CAG
Procedure: Intravascular ultrasound
During CAG Intravascular Ultrasound will be performed in the three coronary arteries
Procedure: Blood sample
a blood sample at baseline after 3 months and at the end of the follow up (after 12 months)
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Atherosclerosis without thrombosis is rarely fatal. It is the acute thrombotic complications which account for disability and death. Therefore, for event-free survival, the question is not why atherosclerosis develops but rather why atherosclerosis, after years after indolent growth, suddenly becomes complicated with luminal thrombosis.
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:
Research plan:
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Maiken Dalager, Ph.D.student | maiken_r@hotmail.com |
Denmark | |
Department of Cardiology, Aarhus University hospital, Skejby | Recruiting |
Aarhus N, Denmark, 8200 | |
Contact: Maiken Dalager, Ph.D.student maiken_r@hotmail.com | |
Principal Investigator: Maiken Dalager, Ph.D.student |
Study Director: | Hans Erik Boetker, MD,PhD,DMSc | Department of Cardiology, Aarhus University hospital, Skejby |
Responsible Party: | Aarhus University hospital, Skejby ( phd stduent, md, Maiken Glud Dalager ) |
Study ID Numbers: | MDCT2403 |
Study First Received: | June 4, 2007 |
Last Updated: | July 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00482651 |
Health Authority: | Denmark: Danish Dataprotection Agency |
Arterial Occlusive Diseases Coronary Disease Atherosclerosis Heart Diseases Myocardial Ischemia |
Vascular Diseases Ischemia Arteriosclerosis Coronary Artery Disease |
Cardiovascular Diseases |