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Clinical Trials/NCT00482651
NCT00482651CompletedNot Applicable

Imaging of Vulnerable Plaques in Coronary Artery Disease by Multidetector Computed Tomography

University of Aarhus1 site in 1 country60 target enrollmentStarted: November 1, 2007Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
60
Locations
1
Primary Endpoint
Ability to identify and characterise atherosclerotic plaques by multidetector CT

Study Overview

Brief Summary

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.

Detailed Description

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Unstable angina pectoris Stable angina pectoris

Exclusion Criteria

  • •known allergy towards the contrast agent not able to hold ones breath for 20 seconds pulmonal, renal or heart failure, cancer, or inflammatory disease arrythmia intolerant to treatment with beta-blockers claustrophobia, pregnancy, breast-feeding previous bypass surgery or PCI continuing breast pain

Arms & Interventions

UAP, SAP

Experimental

Intervention: Blood sample (Procedure)

UAP, SAP

Experimental

Intervention: Coronary angiography (CAG) (Procedure)

UAP, SAP

Experimental

Intervention: Intravascular ultrasound (Procedure)

UAP, SAP

Experimental

Intervention: Multidetector computed tomography scanning (Radiation)

Outcomes

Primary Outcomes

Ability to identify and characterise atherosclerotic plaques by multidetector CT

Time Frame: immediately after the CT-scanning

Secondary Outcomes

  • The impact of different CT-parameters on the ability to identify and characterise atherosclerotic plaques(immediately after the CT-scanning)
  • the growth/development of atherosclerosis(one year)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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