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
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
Subjects having known heart disease including but not limited to
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)
Factorial
MRI scan - obj 1
DeviceFor 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
DeviceFor 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
DeviceFor 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
DeviceFor 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).
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
Numerous exploratory secondary endpoints are sought around the listed measurements across MRI systems and disease states
Click on the lead sponsor to view all of their trials.
