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

Conditions

• CAD

Eligibility Criteria

Sex

ALL

Age

18 Years - 100 Years

Healthy Volunteers

Accepted

Interventions

• 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).
• 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.
• 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.
• 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).

Study Details

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 ...

Key Dates

Start date

Jan 5, 2018

Status verified

Jun 2026

Primary completion

May 31, 2026

Completion

May 31, 2026

Study Design

Enrollment

2,950 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

DIAGNOSTIC

Arms

• Other: Group A
  Group A includes 600 healthy adult volunteers of both sexes with-out known cardiovascular disease
• Other: 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
• Other: Group C
  Group C includes 500 adult subjects of both sexes with known non-cardiovascular disease

Primary Outcome Measure

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 ]

Central Contacts

• Anastasia Tsakirellis, C.R.N.P.
  (301) 921-6986
  [email protected]
• Adrienne E Campbell, Ph.D.
  (301) 480-4080
  [email protected]

Locations (1)

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