Technical Development of Cardiovascular Magnetic Resonance Imaging (CMR) Using a Low Specific Absorption Rate (SAR) Scanner System
Overview
- Phase
- Not Applicable
- Intervention
- MRI scan - obj 1
- Conditions
- CAD
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
- Enrollment
- 2950
- Locations
- 1
- Primary Endpoint
- Technical feasibility and Non-inferiority of the above measurements and examinations ob-tained using low SAR CMR versus commercial CMR in healthy volun-teers and in patients with heart disease
- Status
- Recruiting
- Last Updated
- 18 days ago
Overview
Brief Summary
Background:
Researchers are testing version of a system known as a magnetic resonance imagining (MRI) scanner that uses strong magnetic fields, radio waves and the like to create images of the organs in the body. 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.
Objective:
To test a new MRI scanner and software changes to create better pictures.
Eligibility:
People with disease and healthy volunteers, ages 18 and older.
Design:
Participants will be screened with blood tests.
Participants may have both the new MRI and a conventional MRI 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.
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
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •INCLUSION CRITERIA:
- •Inclusion Criteria for All Participants (Objectives 1, 2, 3, and 4)
- •Men and women age greater than or equal to 18 years
- •Able to provide informed consent in writing
- •Willingness to cooperate with all study procedures (including food restriction) and available for scheduled study events
- •Inclusion Criteria for Healthy Volunteers (Objectives 1 and 2)
- •Currently healthy, self-reported
- •Inclusion Criteria for Subjects with Heart Disease (Objective 3)
- •Subjects having known heart disease including but not limited to
- •Stable angina pectoris due to epicardial coronary artery obstruction
Exclusion Criteria
- •Exclusion Criteria for All Participants:
- •Conditions that are thought to make MRI unsafe (that will be determined by filling out a separate form) including:
- •Cerebral aneurysm clip unless it is labeled safe for MRI
- •Neural stimulator (e.g. TENS-Unit) unless it is labeled safe for MRI
- •Any type of ear implant unless it is labeled safe for MRI
- •Ocular foreign body (e.g. metal shavings)
- •Metal shrapnel or bullet
- •Any implanted device (e.g. insulin pump, drug infusion device), unless it is labeled safe for MRI
- •Pregnancy. When uncertain, subjects will undergo either urine or serum pregnancy testing. Results from up to 3 days prior to the examination will be used. Post-menopausal and surgically sterilized subjects are exempt from this testing.
- •If a urine or serum pregnancy test was administered as part of a referral protocol, and the test was administered up to 3 days prior to MRI examination for this protocol, a new pregnancy test will not be required for this protocol.
Arms & Interventions
Group A
Group A includes 600 healthy adult volunteers of both sexes with-out known cardiovascular disease
Intervention: MRI scan - obj 1
Group A
Group A includes 600 healthy adult volunteers of both sexes with-out known cardiovascular disease
Intervention: MRI scans - obj 2
Group B
Group B includes 500 adult subjects of both sexes with known sta-ble 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
Intervention: MRI scans - obj 3
Group C
Group C includes 500 adult subjects of both sexes with known non-cardiovascular disease
Intervention: MRI scans - obj 4
Outcomes
Primary Outcomes
Technical feasibility and Non-inferiority of the above measurements and examinations ob-tained using low SAR CMR versus commercial CMR in healthy volun-teers and in patients with heart disease
Time Frame: 72 months
To determine whether the the low SAR CMR is a feasible alternative to standard CMR
Secondary Outcomes
- Numerous exploratory secondary endpoints are sought around the listed measurements across MRI systems and disease states(60 months)