Coronary Artery DiseaseNCT00456950
Magnetic Resonance Imaging of the Coronary Vessel Wall
An observational study of Coronary Artery Disease, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
Despite advances in prevention and treatment, clinical manifestations of atherosclerosis (e.g. myocardial infarction, stroke) remain the largest cause of mortality in the Western world. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 75 participants
- Where
- 1 siteNetherlands
- Study dates
- Oct 2005to Jun 2008
- Phase
- Observational
- 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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: * Patients with (un)stable angina or non-st-elevated myocardial infarction: sample from dept. of cardiology * healthy volunteers: community sample
Who may be able to join
- patients with (un)stable angina or non-ST-elevated myocardial infarction
- patients are scheduled for, or recently had X-ray coronary angiography
- healthy volunteers, no clinical history of coronary artery disease(control group for substudy 1)
- patients with non-ischemic heart disease, scheduled for X-ray coronary angiography (control group for substudy 2)
- informed consent
Who cannot join
- severe arrhythmia
- hemodynamic unstable patients
- contra-indications for MRI
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Detection of Vulnerable Plaque With Coronary Vessel Wall Magnetic Resonance Imaging
Despite advances in prevention and treatment, clinical manifestations of atherosclerosis (e.g. myocardial infarction, stroke) remain the largest cause of mortality in the Western world. The occurrence of acute ischemic syndromes, including unstable angina and myocardial infarction, is highly associated with atherosclerotic plaque morphology.
Magnetic resonance (MR) imaging is able to noninvasively depict the lumen of coronary arteries without the need for ionizing radiation. In addition, MR imaging is able to generate soft-tissue contrast unlike any other imaging modality. It has been shown in the aorta and carotid artery that MR imaging is able to identify different atherosclerotic plaque components in vivo. Similar MR imaging techniques are becoming available to visualize the coronary arterial wall and preliminary studies have shown the feasibility of MR coronary vessel wall imaging in humans.
Read more
The overall aim of the current study is to identify in vivo MR coronary vessel wall and plaque features that are associated with acute coronary syndromes. This study is divided into 2 substudies:
- Detection of atherosclerosis in the coronary vessel wall with contrast-enhanced MR imaging in patients with coronary artery disease and age-matched healthy volunteers.
- Characterization of coronary vessel wall plaque morphology in patients with stable and unstable angina: validation of MRI with the current standard of reference intravascular ultrasound (IVUS).
- Conditions
- Coronary Artery Disease
- Keywords
- coronary atherosclerosis, magnetic resonance imaging, vulnerable plaque
- Medical subject headings
- Coronary Artery Disease
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2007 (estimated)
- Study startOct 2005
- Primary completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Tim Leiner, MD, PhD, Principal investigator, Maastricht University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00456950
- Sponsor's protocol ID
- MEC 04-272
- Status last verified
- Sep 2009
- First submitted
- 4 Apr 2007
- Last updated
- 24 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Gerretsen SC, Kooi ME, Kessels AG, Schalla S, Katoh M, van der Geest RJ, Manning WJ, Waltenberger J, van Engelshoven JM, Botnar RM, Leiner T. Visualization of coronary wall atherosclerosis in asymptomatic subjects and patients with coronary artery disease using magnetic resonance imaging. PLoS One. 2010 Sep 29;5(9):e12998. doi: 10.1371/journal.pone.0012998.
PubMed 20927368
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Vulnerable Plaque With Coronary Vessel Wall Magnetic Resonance Imaging
- ClinicalTrials.gov ID
- NCT00456950
- Acronym / sponsor ID
- MEC 04-272
- Conditions
- Coronary Artery Disease
- Keywords
- coronary atherosclerosis, magnetic resonance imaging, vulnerable plaque
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Oct 2005
- Primary completion
- Jun 2008 (actual)
- First posted
- 5 Apr 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.
Despite advances in prevention and treatment, clinical manifestations of atherosclerosis (e.g. myocardial infarction, stroke) remain the largest cause of mortality in the Western world. The occurrence of acute ischemic syndromes, including unstable angina and myocardial infarction, is highly associated with atherosclerotic plaque morphology.
Magnetic resonance (MR) imaging is able to noninvasively depict the lumen of coronary arteries without the need for ionizing radiation. In addition, MR imaging is able to generate soft-tissue contrast unlike any other imaging modality. It has been shown in the aorta and carotid artery that MR imaging is able to identify different atherosclerotic plaque components in vivo. Similar MR imaging techniques are becoming available to visualize the coronary arterial wall and preliminary studies have shown the feasibility of MR coronary vessel wall imaging in humans.
The overall aim of the current study is to identify in vivo MR coronary vessel wall and plaque features that are associated with acute coronary syndromes. This study is divided into 2 substudies:
- Detection of atherosclerosis in the coronary vessel wall with contrast-enhanced MR imaging in patients with coronary artery disease and age-matched healthy volunteers.
- Characterization of coronary vessel wall plaque morphology in patients with stable and unstable angina: validation of MRI with the current standard of reference intravascular ultrasound (IVUS).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- * Patients with (un)stable angina or non-st-elevated myocardial infarction: sample from dept. of cardiology * healthy volunteers: community sample
Key inclusion criteria (5 listed)
- patients with (un)stable angina or non-ST-elevated myocardial infarction
- patients are scheduled for, or recently had X-ray coronary angiography
- healthy volunteers, no clinical history of coronary artery disease(control group for substudy 1)
- patients with non-ischemic heart disease, scheduled for X-ray coronary angiography (control group for substudy 2)
- informed consent
Key exclusion criteria (3 listed)
- severe arrhythmia
- hemodynamic unstable patients
- contra-indications for MRI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 24 Sep 2009.
- Derived from this study: PubMed 20927368Gerretsen SC, Kooi ME, Kessels AG, Schalla S, Katoh M, van der Geest RJ, Manning WJ, Waltenberger J, van Engelshoven JM, Botnar RM, Leiner T. Visualization of coronary wall atherosclerosis in asymptomatic subjects and patients with coronary artery disease using magnetic resonance imaging. PLoS One. 2010 Sep 29;5(9):e12998. doi: 10.1371/journal.pone.0012998.
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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.
Tim Leiner, MD, PhD principal investigator
Maastricht University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Maastricht University Medical Center at 1 site in Netherlands.
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 5 inclusion and 3 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 24 Sep 2009. 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 Netherlands. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00456950, which also lists 1 linked publication.
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 24 Sep 2009.