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

NCT00482651 | Completed DMC

• 1 other identifier: MDCT2403
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Atherosclerosis

Outcome Measures

Primary Outcomes (1)

• Ability to identify and characterise atherosclerotic plaques by multidetector CT

  immediately after the CT-scanning

Secondary Outcomes (2)

• 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

Study Arms (1)

UAP, SAP

EXPERIMENTAL

Radiation: Multidetector computed tomography scanning; Procedure: Coronary angiography (CAG); Procedure: Intravascular ultrasound; Procedure: Blood sample

Interventions

Multidetector computed tomography scanning RADIATION

contrast Multidetector CT-scanning

Also known as: Philips Brilliance 64

UAP, SAP

Coronary angiography (CAG) PROCEDURE

CAG and if necessary PCI. Included patients are already assigned for CAG

UAP, SAP

Intravascular ultrasound PROCEDURE

During CAG Intravascular Ultrasound will be performed in the three coronary arteries

Also known as: Volcano / virtual histology

UAP, SAP

Blood sample PROCEDURE

a blood sample at baseline after 3 months and at the end of the follow up (after 12 months)

UAP, SAP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Unstable angina pectoris Stable angina pectoris

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aarhus: lead
• Danish Research Agency: collaborator
• Philips Medical Systems: collaborator
• Danish Heart Foundation: collaborator

Study Sites (1)

Department of Cardiology, Aarhus University hospital, Skejby

Aarhus N, 8200, Denmark

Location

MeSH Terms

Conditions

Atherosclerosis

Interventions

Ultrasonography, Interventional; Blood Specimen Collection

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Ultrasonography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Specimen Handling; Clinical Laboratory Techniques; Punctures; Investigative Techniques

Study Officials

• Hans Erik Boetker, MD,PhD,DMSc

  Aarhus University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2007
• First Posted: June 5, 2007
• Study Start: November 1, 2007
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: January 23, 2012

Record last verified: 2012-01

Locations

DK (1)