Coronary Artery DiseaseNCT00417625
Validation of MRI Measurement of Cardiac Blood Flow
An observational study of Coronary Artery Disease, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
Trial summary
This study will test the accuracy of magnetic resonance imaging (MRI) in measuring cardiac perfusion (blood flow). MRI of the heart can measure blood flow to heart muscle, but collateral coronary arteries (vessels that supply blood to the heart muscle) may reduce the accuracy of the measurements. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Dec 2006to 19 Jul 2010
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with known or suspected cardiovascular disease
- Age above age 21 (coronary artery disease is rare in subjects less than age 21)
- Undergoing medically necessary coronary arteriography
- Written informed consent
- The subject must allow access to the use of previous medical information from NIH or any institution in order to participate in the research study.
Who cannot join
- Medical Exclusion Criteria:
- Pregnant women (when uncertain, subjects will undergo urine or blood testing) or lactating women
- Decompensated congestive heart failure (unable to lie flat during MRI or catheterization)
- Impaired renal excretory function (calculated Glomerular Filtration Rate less than 30mL/min/1.73m(2)) unless on dialysis.
- MRI Exclusion Criteria (for MRI scan only):
- Cardiac pacemaker or implantable defibrillator
Show all 18Show fewer
- Cerebral aneurysm clip
- Neural stimulator (e.g. TENS-Unit)
- Any type of ear implant
- Ocular foreign body (e.g. metal shavings)
- Any implanted device (e.g. insulin pump, drug infusion device)
- Metal shrapnel or bullet.
- Unable to tolerate dipyridamole:
- -Reactive airways disease (significant asthma or chronic obstructive pulmonary disease and unable to tolerate a beta adrenergic antagonist).
- Post-Hoc Catheterization Exclusion Criteria (determined during coronary arteriography):
- Excessive tortuosity or any angiographic features that, in the opinion of catheterization operator, would make invasive physiology assessments unsafe or unsuitable
- Ongoing myocardial ischemia or other exigency that would make further study participation hazardous
- Normal epicardial coronary arteries and normal perfusion cardiac MRI
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Validation of Cardiac MR Perfusion With Cardiac Catheterization Physiological Assessment
This study will test the accuracy of magnetic resonance imaging (MRI) in measuring cardiac perfusion (blood flow). MRI of the heart can measure blood flow to heart muscle, but collateral coronary arteries (vessels that supply blood to the heart muscle) may reduce the accuracy of the measurements. This study will perform special measurements of coronary artery flow and pressure in patients undergoing heart catheterization and catheter-based treatment (angioplasty and stenting) in order to compare for accuracy with cardiac MRI.
Patients 21 years of age and older with coronary artery blockage may be eligible for this study. All participants undergo cardiac MRI, to produce images of the heart, as well as special invasive blood flow testing during heart catheterization, angioplasty, and stenting.
Read more
During MRI, the subject lies on a table that can slide in and out of the scanner (a narrow cylinder), wearing earplugs to muffle loud knocking and thumping sounds that occur during the scanning process. The procedure lasts about 45 to 90 minutes. Since the heart moves during breathing, subjects are asked to hold their breath intermittently for about 5-20 seconds. A medicine called dipyridamole is injected through a vein in the subject's arm to increase blood flow to the coronary arteries and help detect blockages. Pictures are taken of the heart before, during, and after the dipyridamole injection. Another medicine called gadolinium is also given through a vein. This medicine brightens the images to measure blood flow.
During a separate catheterization, angioplasty, and stenting procedure, subjects undergo additional invasive tests. The additional tests use a special guidewire to measure coronary artery pressure and blood flow, as well as a special ultrasound to look inside the artery.
Patients have a repeat MRI about 2 months after the catheterization.
Read the detailed description
Cardiac magnetic resonance imaging (MRI) can measure perfusion (blood flow) to heart muscle. Collateral coronary arteries (natural bypasses to the heart) may reduce the accuracy of perfusion measured by cardiac MRI.
We are testing the accuracy of these measurements in subjects undergoing medically necessary cardiac catheterization and catheter-based treatment (angioplasty and stenting). We will perform special invasive measurements of coronary artery flow and pressure during catheterization in order to compare with cardiac MRI.
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary Artery Perfusion, MRI, Fractional Flow Reserve, Coronary Flow Reserve, Collateral Artery Perfusion, Cardiovascular Disease, Coronary Artery Disease, CAD
- Medical subject headings
- Coronary Artery Disease, Cardiovascular Diseases
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2007 (estimated)
- Study start29 Dec 2006
- Study completion19 Jul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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 National Heart, Lung, and Blood Institute (NHLBI)The 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
- Time perspective
- Prospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00417625
- Sponsor's protocol ID
- 070056
- Other IDs
- 07-H-0056
- Status last verified
- 19 Jul 2010
- First submitted
- 30 Dec 2006
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Muehling OM, Jerosch-Herold M, Panse P, Zenovich A, Wilson BV, Wilson RF, Wilke N. Regional heterogeneity of myocardial perfusion in healthy human myocardium: assessment with magnetic resonance perfusion imaging. J Cardiovasc Magn Reson. 2004;6(2):499-507. doi: 10.1081/jcmr-120030570.
PubMed 15137334Jerosch-Herold M, Swingen C, Seethamraju RT. Myocardial blood flow quantification with MRI by model-independent deconvolution. Med Phys. 2002 May;29(5):886-97. doi: 10.1118/1.1473135.
PubMed 12033585Muhling OM, Dickson ME, Zenovich A, Huang Y, Wilson BV, Wilson RF, Anand IS, Seethamraju RT, Jerosch-Herold M, Wilke NM. Quantitative magnetic resonance first-pass perfusion analysis: inter- and intraobserver agreement. J Cardiovasc Magn Reson. 2001;3(3):247-56. doi: 10.1081/jcmr-100107473.
PubMed 11816621
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Cardiac MR Perfusion With Cardiac Catheterization Physiological Assessment
- ClinicalTrials.gov ID
- NCT00417625
- Acronym / sponsor ID
- 070056
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary Artery Perfusion, MRI, Fractional Flow Reserve, Coronary Flow Reserve, Collateral Artery Perfusion, Cardiovascular Disease, Coronary Artery Disease, CAD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- 29 Dec 2006
- Study completion
- 19 Jul 2010
- First posted
- 4 Jan 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.
This study will test the accuracy of magnetic resonance imaging (MRI) in measuring cardiac perfusion (blood flow). MRI of the heart can measure blood flow to heart muscle, but collateral coronary arteries (vessels that supply blood to the heart muscle) may reduce the accuracy of the measurements. This study will perform special measurements of coronary artery flow and pressure in patients undergoing heart catheterization and catheter-based treatment (angioplasty and stenting) in order to compare for accuracy with cardiac MRI.
Patients 21 years of age and older with coronary artery blockage may be eligible for this study. All participants undergo cardiac MRI, to produce images of the heart, as well as special invasive blood flow testing during heart catheterization, angioplasty, and stenting.
During MRI, the subject lies on a table that can slide in and out of the scanner (a narrow cylinder), wearing earplugs to muffle loud knocking and thumping sounds that occur during the scanning process. The procedure lasts about 45 to 90 minutes. Since the heart moves during breathing, subjects are asked to hold their breath intermittently for about 5-20 seconds. A medicine called dipyridamole is injected through a vein in the subject's arm to increase blood flow to the coronary arteries and help detect blockages. Pictures are taken of the heart before, during, and after the dipyridamole injection. Another medicine called gadolinium is also given through a vein. This medicine brightens the images to measure blood flow.
During a separate catheterization, angioplasty, and stenting procedure, subjects undergo additional invasive tests. The additional tests use a special guidewire to measure coronary artery pressure and blood flow, as well as a special ultrasound to look inside the artery.
Patients have a repeat MRI about 2 months after the catheterization.
Detailed description
Cardiac magnetic resonance imaging (MRI) can measure perfusion (blood flow) to heart muscle. Collateral coronary arteries (natural bypasses to the heart) may reduce the accuracy of perfusion measured by cardiac MRI.
We are testing the accuracy of these measurements in subjects undergoing medically necessary cardiac catheterization and catheter-based treatment (angioplasty and stenting). We will perform special invasive measurements of coronary artery flow and pressure during catheterization in order to compare with cardiac MRI.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with known or suspected cardiovascular disease
- Age above age 21 (coronary artery disease is rare in subjects less than age 21)
- Undergoing medically necessary coronary arteriography
- Written informed consent
- The subject must allow access to the use of previous medical information from NIH or any institution in order to participate in the research study.
Key exclusion criteria (18 listed)
- Pregnant women (when uncertain, subjects will undergo urine or blood testing) or lactating women
- Decompensated congestive heart failure (unable to lie flat during MRI or catheterization)
- Impaired renal excretory function (calculated Glomerular Filtration Rate less than 30mL/min/1.73m(2)) unless on dialysis.
- Cardiac pacemaker or implantable defibrillator
- Cerebral aneurysm clip
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 2 Jul 2017.
- Background: PubMed 15137334Muehling OM, Jerosch-Herold M, Panse P, Zenovich A, Wilson BV, Wilson RF, Wilke N. Regional heterogeneity of myocardial perfusion in healthy human myocardium: assessment with magnetic resonance perfusion imaging. J Cardiovasc Magn Reson. 2004;6(2):499-507. doi: 10.1081/jcmr-120030570.
- Background: PubMed 12033585Jerosch-Herold M, Swingen C, Seethamraju RT. Myocardial blood flow quantification with MRI by model-independent deconvolution. Med Phys. 2002 May;29(5):886-97. doi: 10.1118/1.1473135.
- Background: PubMed 11816621Muhling OM, Dickson ME, Zenovich A, Huang Y, Wilson BV, Wilson RF, Anand IS, Seethamraju RT, Jerosch-Herold M, Wilke NM. Quantitative magnetic resonance first-pass perfusion analysis: inter- and intraobserver agreement. J Cardiovasc Magn Reson. 2001;3(3):247-56. doi: 10.1081/jcmr-100107473.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 National Heart, Lung, and Blood Institute (NHLBI) 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 5 inclusion and 18 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 2 Jul 2017. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00417625, which also lists 3 linked publications.
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 2 Jul 2017.