AtherosclerosisNCT00482651
Imaging of Vulnerable Plaques in Coronary Artery Disease by Multidetector Computed Tomography
A study testing Multidetector computed tomography scanning, Coronary angiography (CAG) and Intravascular ultrasound in people with Atherosclerosis, run by University of Aarhus at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atherosclerosis
- What is being tested?
- Multidetector computed tomography scanning, Coronary angiography (CAG) and Intravascular ultrasound
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2007to Jan 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unstable angina pectoris Stable angina pectoris
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Cardiology, Aarhus University hospital, Skejby
Aarhus N, 8200
About this study
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.
Read more
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:
- 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.
- 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.
- A prospective, longitudinal study. After a period of 12 months all patients from sub-study 2 will be re-investigated.
- 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:
- Development of an MDCT scan protocol for accurate assessment of coronary artery plaque composition.
- 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.
- 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
- Atherosclerosis
- Being tested
- Multidetector computed tomography scanning, Coronary angiography (CAG), Intravascular ultrasound, Blood sample
- Medical subject headings
- Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multidetector computed tomography scanningRadiation
Also called Philips Brilliance 64
contrast Multidetector CT-scanning
Coronary angiography (CAG)Procedure or surgery
CAG and if necessary PCI. Included patients are already assigned for CAG
Intravascular ultrasoundProcedure or surgery
Also called Volcano / virtual histology
During CAG Intravascular Ultrasound will be performed in the three coronary arteries
Blood sampleProcedure or surgery
a blood sample at baseline after 3 months and at the end of the follow up (after 12 months)
| Study group | Role | What they receive |
|---|---|---|
| UAP, SAP | Experimental | Not described Receives: Radiation: Multidetector computed tomography scanning; Procedure: Coronary angiography (CAG); Procedure: Intravascular ultrasound; Procedure: Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability to identify and characterise atherosclerotic plaques by multidetector CT
Measured: immediately after the CT-scanning
Secondary outcomes (2)
The impact of different CT-parameters on the ability to identify and characterise atherosclerotic plaques
Measured: immediately after the CT-scanning
the growth/development of atherosclerosis
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2007 (estimated)
- Study startNov 2007
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtherosclerosisStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Danish Research Agency, Philips Medical Systems, Danish Heart Foundation
- Responsible party
- Sponsor
- Investigators
- Hans Erik Boetker, MD,PhD,DMSc, Study director, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00482651
- Sponsor's protocol ID
- MDCT2403
- Status last verified
- Jan 2012
- First submitted
- 4 Jun 2007
- Last updated
- 23 Jan 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging of Vulnerable Plaques in Coronary Artery Disease by Multidetector Computed Tomography
- ClinicalTrials.gov ID
- NCT00482651
- Acronym / sponsor ID
- MDCT2403
- Conditions
- Atherosclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Danish Research Agency, Philips Medical Systems, Danish Heart Foundation
- Study start
- Nov 2007
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 5 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
1b) identify vulnerable plaques.
Materials and methods:
- 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.
- 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.
- A prospective, longitudinal study. After a period of 12 months all patients from sub-study 2 will be re-investigated.
- 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:
- Development of an MDCT scan protocol for accurate assessment of coronary artery plaque composition.
- 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.
- 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| UAP, SAP | Experimental | Radiation: Multidetector computed tomography scanning, Procedure: Coronary angiography (CAG), Procedure: Intravascular ultrasound, Procedure: Blood sample |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Unstable angina pectoris Stable angina pectoris
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multidetector computed tomography scanningAlso: Philips Brilliance 64contrast Multidetector CT-scanning | Radiation | UAP, SAP |
| Coronary angiography (CAG)CAG and if necessary PCI. Included patients are already assigned for CAG | Procedure or surgery | UAP, SAP |
| Intravascular ultrasoundAlso: Volcano / virtual histologyDuring CAG Intravascular Ultrasound will be performed in the three coronary arteries | Procedure or surgery | UAP, SAP |
| Blood samplea blood sample at baseline after 3 months and at the end of the follow up (after 12 months) | Procedure or surgery | UAP, SAP |
Primary outcome
Ability to identify and characterise atherosclerotic plaques by multidetector CT
Time frame: immediately after the CT-scanning
2 secondary outcomes
The impact of different CT-parameters on the ability to identify and characterise atherosclerotic plaques
Time frame: immediately after the CT-scanning
the growth/development of atherosclerosis
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hans Erik Boetker, MD,PhD,DMSc study director
Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multidetector computed tomography scanning, Coronary angiography (CAG) and Intravascular ultrasound in people with Atherosclerosis, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ability to identify and characterise atherosclerotic plaques by multidetector CT (time frame: immediately after the CT-scanning). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2012.