Coronary ArteriosclerosisNCT00353795
Coronary Atherosclerosis Evaluation by Arterial Wall Magnetic Resonance Imaging (MRI)
A study testing MR Imaging of the Coronary Arteries in people with Coronary Arteriosclerosis and Arteriosclerosis, Coronary, run by Johns Hopkins University at 2 sites in United States.
Trial summary
The overall goal of this study is to use MRI to: Examine the relationship between known risk factors for cardiovascular disease and coronary artery wall thickness; Examine the relationship between coronary artery wall thickness and other markers of subclinical coronary atherosclerosis, such as carotid wall thickness… Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Coronary Arteriosclerosis, Arteriosclerosis, Coronary, Atherosclerosis, Coronary
- What is being tested?
- MR Imaging of the Coronary Arteries
- Type of treatment
- Surgery or procedure
- How many people
- 179 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2005to Jun 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Prior enrollment in the MESA Study at the Hopkins MESA Field Center or the Northwestern University MESA Field Center
- Male or Female adult equal to or older than 45 years of age
- Willing/able to provide informed consent
Who cannot join
- Any known contraindications to MRI (i.e. severe claustrophobia, pacemaker, etc.)
- Metal in the eyes
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Johns Hopkins MESA Field Center
Baltimore, Maryland, 21244
Northwestern University MESA Field Center
Chicago, Illinois, 60611
About this study
Official title: Coronary Atherosclerosis Evaluation by Arterial Wall MRI
The overall goal of this study is to use MRI to:
- Examine the relationship between known risk factors for cardiovascular disease and coronary artery wall thickness;
- Examine the relationship between coronary artery wall thickness and other markers of subclinical coronary atherosclerosis, such as carotid wall thickness and coronary calcium scores; and,
- Examine the feasibility of measuring the progression of coronary artery wall thickness over time in a subset of participants.
Read the detailed description
Each enrolled participant will undergo MR Imaging of the coronary arteries in conjunction with their routine MESA follow-up visit. The MRI will last approximately 45-60 minutes
- Conditions
- Coronary Arteriosclerosis, Arteriosclerosis, Coronary, Atherosclerosis, Coronary, Coronary Artery Disease, Coronary Atherosclerosis
- Being tested
- MR Imaging of the Coronary Arteries
- Keywords
- MESA, MRI, Cardiovascular, Cardiac, Coronary, Atherosclerosis
- Medical subject headings
- Coronary Artery Disease, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MR Imaging of the Coronary ArteriesProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Coronary Wall Thickness
Average thickness of the wall of the left anterior descending, right and left main coronary artery measured by magnetic resonance imaging (MRI).
Measured: n/a (cross sectional analysis)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2006 (estimated)
- Study startJul 2005
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Coronary ArteriosclerosisStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 179 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Northwestern University
- Investigators
- David A Bluemke, MD PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00353795
- Sponsor's protocol ID
- 05-05-23-01
- Other IDs
- 5R01HL078909
- Status last verified
- Sep 2009
- First submitted
- 18 Jul 2006
- Last updated
- 22 Jun 2010
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coronary Atherosclerosis Evaluation by Arterial Wall MRI
- ClinicalTrials.gov ID
- NCT00353795
- Acronym / sponsor ID
- 05-05-23-01
- Conditions
- Coronary Arteriosclerosis, Arteriosclerosis, Coronary, Atherosclerosis, Coronary, Coronary Artery Disease, Coronary Atherosclerosis
- Keywords
- MESA, MRI, Cardiovascular, Cardiac, Coronary, Atherosclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 179 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Northwestern University
- Study start
- Jul 2005
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 19 Jul 2006 (estimated)
- Results
- Posted 22 Jun 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall goal of this study is to use MRI to:
- Examine the relationship between known risk factors for cardiovascular disease and coronary artery wall thickness;
- Examine the relationship between coronary artery wall thickness and other markers of subclinical coronary atherosclerosis, such as carotid wall thickness and coronary calcium scores; and,
- Examine the feasibility of measuring the progression of coronary artery wall thickness over time in a subset of participants.
Detailed description
Each enrolled participant will undergo MR Imaging of the coronary arteries in conjunction with their routine MESA follow-up visit. The MRI will last approximately 45-60 minutes
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Prior enrollment in the MESA Study at the Hopkins MESA Field Center or the Northwestern University MESA Field Center
- Male or Female adult equal to or older than 45 years of age
- Willing/able to provide informed consent
Key exclusion criteria (2 listed)
- Any known contraindications to MRI (i.e. severe claustrophobia, pacemaker, etc.)
- Metal in the eyes
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 |
|---|---|---|
| MR Imaging of the Coronary Arteries | Procedure or surgery | – |
Primary outcome
Mean Coronary Wall Thickness
Time frame: n/a (cross sectional analysis)
Average thickness of the wall of the left anterior descending, right and left main coronary artery measured by magnetic resonance imaging (MRI).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Multi-Ethnic Study of Atherosclerosis webpageLink provided by the sponsor.
Related trials for Coronary Arteriosclerosis
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Active, not recruiting
The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
Ischaemic Heart Disease, Ischemic Heart Disease
RecruitingEarly Phase 1
Thiamine Intervention and Coronary Artery Bypass Grafting
Coronary Heart Disease, Coronary Artery Bypass Grafting
Active, not recruitingObservational study
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
Hypertension, Diabetes
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.
David A Bluemke, MD PhD principal investigator
Johns Hopkins University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MR Imaging of the Coronary Arteries in people with Coronary Arteriosclerosis and Arteriosclerosis, Coronary, run by Johns Hopkins University at 2 sites in United States.
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 3 inclusion and 2 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 22 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
Yes. Results are posted in the registry (first posted 22 Jun 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Coronary Wall Thickness (time frame: n/a (cross sectional analysis)). 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 22 Jun 2010.