Coronary Artery DiseaseNCT00166179
Magnetic Resonance Imaging (MRI) Viability: Comparison of Myocardial Viability by Positron Emission Tomography and MRI
An observational study of Coronary Artery Disease, run by Emory University at 1 site in United States.
Trial summary
The purpose of this study is to compare cardiac MRI with positron emission tomography (PET) with fluorodeoxyglucose (FDG) to determine if cardiac MRI images are as good as, or better, than PET with FDG. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2003to Oct 2006
- 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 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Age > 25 yrs, mean + SD = 60.3 + 10.2, 83% male, are patients referred by cardiologist or cardiac surgeon for assessment of myocardial viability by PET FDG.
Who may be able to join
- PET-FDG ordered to assess myocardial viability
Who cannot join
- Contraindicated for MRI
- Pregnant
- Age <25 yrs
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to compare cardiac MRI with positron emission tomography (PET) with fluorodeoxyglucose (FDG) to determine if cardiac MRI images are as good as, or better, than PET with FDG.
- Conditions
- Coronary Artery Disease
- Keywords
- CAD
- Medical subject headings
- Coronary Artery Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Magnetic Resonance Imaging (MRI) Viability: Comparison of Myocardial Viability by Positron Emission Tomography and MRI
Measured: time of initial scans
Secondary outcomes (1)
Compare size of regions of viable and non viable myocardium as % left ventricle by MRI vs. PET
Measured: at time of initial scans
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startNov 2003
- Primary completionOct 2006
- Study completionOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Emory 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Randolph E Patterson, Emory University
- Investigators
- Randolph Patterson, MD, Principal investigator, Staff
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00166179
- Sponsor's protocol ID
- IRB00000292
- Other IDs
- 6-56550
- Status last verified
- Sep 2014
- First submitted
- 13 Sep 2005
- Last updated
- 26 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Resonance Imaging (MRI) Viability: Comparison of Myocardial Viability by Positron Emission Tomography and MRI
- ClinicalTrials.gov ID
- NCT00166179
- Acronym / sponsor ID
- IRB00000292
- Conditions
- Coronary Artery Disease
- Keywords
- CAD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Nov 2003
- Primary completion
- Oct 2006 (actual)
- Study completion
- Oct 2006 (actual)
- First posted
- 14 Sep 2005 (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.
The purpose of this study is to compare cardiac MRI with positron emission tomography (PET) with fluorodeoxyglucose (FDG) to determine if cardiac MRI images are as good as, or better, than PET with FDG.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Age > 25 yrs, mean + SD = 60.3 + 10.2, 83% male, are patients referred by cardiologist or cardiac surgeon for assessment of myocardial viability by PET FDG.
Key inclusion criteria (1 listed)
- PET-FDG ordered to assess myocardial viability
Key exclusion criteria (3 listed)
- Contraindicated for MRI
- Pregnant
- Age <25 yrs
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
Magnetic Resonance Imaging (MRI) Viability: Comparison of Myocardial Viability by Positron Emission Tomography and MRI
Time frame: time of initial scans
1 secondary outcome
Compare size of regions of viable and non viable myocardium as % left ventricle by MRI vs. PET
Time frame: at time of initial scans
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 26 Sep 2014.
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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.
Randolph Patterson, MD principal investigator
Staff
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 Emory University at 1 site 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 1 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 26 Sep 2014. 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 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?
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?
Magnetic Resonance Imaging (MRI) Viability: Comparison of Myocardial Viability by Positron Emission Tomography and MRI (time frame: time of initial scans). 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 26 Sep 2014.