Technical Development of Cardiovascular Magnetic Resonance Imaging (CMR) Using a Low Specific Absorption Rate (SAR) Scanner System
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|ClinicalTrials.gov Identifier: NCT03331380|
Recruitment Status : Recruiting
First Posted : November 6, 2017
Last Update Posted : February 28, 2019
Researchers are testing a new kind of magnetic resonance imaging (MRI) scanner to take pictures of the heart. It uses lower energy levels than other MRI scanners. This may help scan people with metal devices in their body, or in invasive heart procedures using metal tools.
To test new MRI scanners and software changes to create better pictures of the heart.
People with heart disease and healthy volunteers, ages 18 and older
Participants will be screened with blood tests.
Participants with heart disease will have both the new MRI and a conventional MRI. Healthy participants will have both MRIs or only the new one. If 2 are done, they must be within 60 days.
For both MRI versions, participants lie on a table that slides into a large tube. During scans, they will hold their breath for up to 20 seconds at a time. Heart activity will be measured by wires connected to pads on the skin. A flexible belt may be used to monitor their breathing. They will be in the scanner up to 2 hours.
Participants can agree to have a dye called gadolinium injected into their arm during the scan. This brightens the pictures of the heart.
Participants can agree to take a drug called a vasodilator. This helps detect areas of the heart with abnormal blood supply. Scans of the heart are taken before, during, and after they get the medicine. The drug may cause temporary chest pain or shortness of breath. They may get other drugs to relieve these symptoms.
Sponsoring Institution: National Heart, Lung, and Blood Institute
|Condition or disease||Intervention/treatment||Phase|
|CAD||Device: MRI scan x 1- Healthy volunteer Device: MRI scan x 2- Healthy volunteer Device: MRI scan x 2- CAD patients Device: MRI scan x 2- non-CAD patients||Phase 1 Phase 2|
Cardiac magnetic resonance imaging (CMR) provides accurate and reproducible measures of cardiac chamber volumes, cardiac function, blood flow, myocardial scar, myocardial extracellular volume as a measure of collagen content, myocardial iron content, and others, all without exposure to ionizing radiation. The prevailing wisdom is that CMR using high specific absorption rate (SAR) scanning modes produces highest image quality. We propose a method of CMR that can be performed with low SAR but that nevertheless preserves image quality because of efficient use of CMR signal. CMR using low SAR is attractive because it may reduce heating of metallic structures. This may allow safe CMR in patients with metallic implants, and it may allow MRI catheterization using metallic guidewires and catheter devices.
The goal of this non-significant risk (NSR) medical device study is to test initial technical feasibility of low SAR CMR in healthy volunteers by technical optimization of scanner protocols, to test comparative accuracy of standard CMR measurements in healthy volunteers using low SAR CMR versus conventional CMR, and to test comparative accuracy of standard CMR measurements in adult patients with known stable heart disease using low SAR CMR versus conventional CMR.
A secondary goal is to assess the potential of this new low-SAR CMR system to perform non-cardiovascular radiological diagnostic imaging by testing comparative diagnostic accuracy of standard MR measurements in adult patients with known non-cardiovascular disease using the low SAR CMR system vs conventional MR exam.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||800 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||None (Open Label)|
|Official Title:||Technical Development of Cardiovascular Magnetic Resonance Imaging (CMR) Using a Low Specific Absorption Rate (SAR) Scanner System|
|Actual Study Start Date :||January 5, 2018|
|Estimated Primary Completion Date :||May 30, 2019|
|Estimated Study Completion Date :||December 31, 2019|
Group A includes 150 healthy adult volunteers of both sexes with-out known cardiovascular disease; MRI Scan x 1 for 60 healthy volunteers; MRI Scan x 2 in 60 healthy volunteers
Device: MRI scan x 1- Healthy volunteer
For objective 1 (protocol optimization), healthy volunteers undergo imaging using an investigational low SAR CMR scanner for up to two hours, some without- and some with administration of intravenous gadolinium based contrast agents (GBCAs).
Device: MRI scan x 2- Healthy volunteer
For objective 2 (comparative scanning of normals), healthy volunteers undergo two CMR examinations on two different MRI scan-ners (investigational low SAR CMR and conventional 1.5T CMR), some without- and some with administration of intravenous GBCA.
Group B includes 100 adult subjects of both sexes with known stable cardiovascular disease including adults with stable coronary artery disease after myocardial infarction; adults with heart failure and reduced left ventricular systolic function; adults with pulmonary artery hypertension; adults with congenital heart disease including cardiac shunts; adults with valvular heart disease including aortic stenosis, mitral regurgitation, and tricuspid regurgitation; and adults with metallic cardiovascular implants (such as coronary and peripheral artery stents) known to be safe for CMR at 1.5T.
Device: MRI scan x 2- CAD patients
For objective 3 (comparative scanning of patients), subjects with known stable cardiovascular disease undergo two CMR examinations on two different MRI scanners (investigational low SAR CMR and conventional 1.5T CMR), some without- and some with administration of intravenous GBCA.
Group C includes 100 adult subjects of both sexes with known non-cardiovascular disease
Device: MRI scan x 2- non-CAD patients
For objective 4 (comparative scanning of patients), subjects with known or suspected disease, including neurological, musculoskele-tal disease, abdominal or lung disease, will undergo two MR exami-nations on two different MRI scanners (investigational low SAR CMR and conventional MR).
- Technical feasibility and Non-inferiority of the above measurements and examinations obtained using low SAR CMR versus commercial CMR in healthy volunteers and in patients with heart disease [ Time Frame: 18 months ]To determine whether the the low SAR CRM is a feasible alternative to standard CMR
- Numerous exploratory secondary endpoints are sought around the listed measurements across MRI systems and disease states [ Time Frame: 18 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03331380
|Contact: Annette Stine, R.N.||(301) firstname.lastname@example.org|
|United States, Maryland|
|National Institutes of Health Clinical Center||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 email@example.com|
|Principal Investigator:||Adrienne E Campbell, Ph.D.||National Heart, Lung, and Blood Institute (NHLBI)|