Technical Development of Cardiovascular Magnetic Resonance Imaging (CMR) Using a Low Specific Absorption Rate (SAR) Scanner System

NCT03331380 | Recruiting FDA Device

• 2 other identifiers: 18001118-H-0011
• Study Type: interventional
• Target: 2,950
• Locations: 1 country
• Sites: 1

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

Conditions

CAD

Keywords

1.5 T CMR; Low SAR CMR; Gadolinium; Regadenoson; Adenosine

Outcome Measures

Primary Outcomes (1)

• 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

  To determine whether the the low SAR CMR is a feasible alternative to standard CMR

  72 months

Secondary Outcomes (1)

• Numerous exploratory secondary endpoints are sought around the listed measurements across MRI systems and disease states

  60 months

Study Arms (3)

Group A

OTHER

Group A includes 600 healthy adult volunteers of both sexes with-out known cardiovascular disease

Device: MRI scan - obj 1; Device: MRI scans - obj 2

Group B

OTHER

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

Device: MRI scans - obj 3

Group C

OTHER

Group C includes 500 adult subjects of both sexes with known non-cardiovascular disease

Device: MRI scans - obj 4

Interventions

MRI scans - obj 4 DEVICE

For objective 4 (comparative scanning of patients), subjects with known or suspected disease, including neurological, musculoskeletal disease, abdominal or lung disease, will undergo two MR examinations on two different MRI scanners (investigational low SAR CMR and conventional MR).

Group C

MRI scan - obj 1 DEVICE

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).

Group A

MRI scans - obj 2 DEVICE

For objective 2 (comparative scanning of normals), healthy volunteers 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 A

MRI scans - obj 3 DEVICE

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 B

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Currently healthy, self-reported
• Subjects having known heart disease including but not limited to
• Stable angina pectoris due to epicardial coronary artery obstruction
• Past myocardial infarction
• Heart failure with reduced ejection fraction
• Valvular heart disease
• Pulmonary artery hypertension
• Congenital heart disease with or without prior repair
• Myocarditis
• Infiltrative cardiomyopathy
• Hypertrophic cardiomyopathy
• Having known brain disease including but not limited to:

You may not qualify if:

• 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.
• If a pregnancy test has not been administered within 3 days of MRI examination for this protocol, a serum or urine pregnancy test will be administered. Medical personnel will determine which pregnancy test is appropriate based on subject s medical history, screening, and individual scenario. In addition, the subject will be asked if she may be pregnant prior to the performance of the MRI, even if the pregnancy test was negative within the past week. The pregnancy test will be repeated if she answers in the affirmative.
• When gadolinium based contrast agent (GBCA) exposure is planned
• Objective 1 and 2, Healthy Volunteers: No gadolinium based contrast agent exposure is permitted if eGFR \< 60 mL/min/1.73m\^(2) using the CKD-EPI equation or equivalent and a serum creatinine measured within 2 weeks without intercurrent change in medical condition or medications.
• Objective 3 and 4, Volunteers with Cardiac and Non-Cardiac Disease: No gadolinium based contrast agent exposure is permitted if eGFR \< 30 mL/min/1.73m\^(2) using the CKDEPI equation \[25\] or equivalent and a serum creatinine measured within 2 weeks without
• intercurrent change in medical condition or medications.
• For all objectives not more than two research MRI exams with GBCA exposure in a 12 month period. Research MRI exams performed outside of this protocol will be included in the 12 month period.

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Publications (4)

• Xiang J, Ramasawmy R, Seemann F, Peters DC, Campbell-Washburn AE. Balanced steady-state free precession phase contrast at 0.55T applied to aortic flow. J Cardiovasc Magn Reson. 2024 Winter;26(2):101098. doi: 10.1016/j.jocmr.2024.101098. Epub 2024 Sep 13.

  PMID: 39278416 DERIVED

• Campbell-Washburn AE, Jiang Y, Korzdorfer G, Nittka M, Griswold MA. Feasibility of MR fingerprinting using a high-performance 0.55 T MRI system. Magn Reson Imaging. 2021 Sep;81:88-93. doi: 10.1016/j.mri.2021.06.002. Epub 2021 Jun 8.

  PMID: 34116134 DERIVED

• Bandettini WP, Shanbhag SM, Mancini C, Henry JL, Lowery M, Chen MY, Xue H, Kellman P, Campbell-Washburn AE. Evaluation of Myocardial Infarction by Cardiovascular Magnetic Resonance at 0.55-T Compared to 1.5-T. JACC Cardiovasc Imaging. 2021 Sep;14(9):1866-1868. doi: 10.1016/j.jcmg.2021.02.024. Epub 2021 May 19. No abstract available.

  PMID: 34023254 DERIVED

• Bandettini WP, Shanbhag SM, Mancini C, McGuirt DR, Kellman P, Xue H, Henry JL, Lowery M, Thein SL, Chen MY, Campbell-Washburn AE. A comparison of cine CMR imaging at 0.55 T and 1.5 T. J Cardiovasc Magn Reson. 2020 May 18;22(1):37. doi: 10.1186/s12968-020-00618-y.

  PMID: 32423456 DERIVED

Related Links

• NIH Clinical Center Detailed Web Page

Study Officials

• Adrienne E Campbell, Ph.D.

  National Heart, Lung, and Blood Institute (NHLBI)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anastasia Tsakirellis, C.R.N.P.

CONTACT

(301) 921-6986; anastasia.tsakirellis@nih.gov

Adrienne E Campbell, Ph.D.

CONTACT

(301) 480-4080; adrienne.campbell@nih.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: FACTORIAL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2017
• First Posted: November 6, 2017
• Study Start: January 5, 2018
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: April 14, 2026

Record last verified: 2026-02-25

Locations

US (1)