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CompletedNCT00482651Updated Jan 23, 2012

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

An interventional study of Multidetector computed tomography scanning and Coronary angiography (CAG) in Atherosclerosis, sponsored by University of Aarhus. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-01-23.

Sponsored by University of Aarhus · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

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.
02

Conditions studied

  • Atherosclerosis

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03

In context

Atherosclerosis

1,596 studies on the registry are indexed under Atherosclerosis; 262 are open to participants now.

This study's enrollment of 60 is below the median of 105 across 898 interventional studies indexed under Atherosclerosis.

Browse Atherosclerosis studies →

Lead sponsor

University of Aarhus is the lead sponsor of 1,299 studies on the registry; 189 are open to participants now.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Unstable angina pectoris Stable angina pectoris

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    UAP, SAP

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

Interventions

  • RadiationMultidetector computed tomography scanning

    contrast Multidetector CT-scanning

    Also known as: Philips Brilliance 64

  • ProcedureCoronary angiography (CAG)

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

  • ProcedureIntravascular ultrasound

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

    Also known as: Volcano / virtual histology

  • ProcedureBlood sample

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

06

What researchers measure

Primary outcomes

  1. Ability to identify and characterise atherosclerotic plaques by multidetector CT

    Time frame: immediately after the CT-scanning

Secondary outcomes

  1. The impact of different CT-parameters on the ability to identify and characterise atherosclerotic plaques

    Time frame: immediately after the CT-scanning

  2. the growth/development of atherosclerosis

    Time frame: one year

07

Study locations

1 site
  • Department of Cardiology, Aarhus University hospital, Skejby
    Aarhus N, 8200, Denmark
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Nov 2007, a primary completion of Jan 2012 and a completion of Jan 2012. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 4, 2007
First posted
Jun 5, 2007
Start
Nov 2007
Primary completionActual
Jan 2012
CompletionActual
Jan 2012
Last update
Jan 23, 2012
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 23, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00482651
Lead sponsor
University of Aarhus
Collaborators
Danish Research Agency, Philips Medical Systems, Danish Heart Foundation
Responsible party
Sponsor
First posted
Jun 5, 2007
Start date
Nov 2007
Primary completion
Jan 2012
Completion
Jan 2012
Last update
Jan 23, 2012

Study contacts

Hans Erik Boetker, MD,PhD,DMSc
study director · Aarhus University Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2012. You cannot join it, but the record below documents what was studied.

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