CAD
Conditions
Keywords
1.5 T CMR, Low SAR CMR, Gadolinium, Regadenoson, Adenosine
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.
Interventions
DEVICEMRI scan - obj 1
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).
DEVICEMRI scans - obj 2
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.
DEVICEMRI scans - obj 3
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.
DEVICEMRI scans - obj 4
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).
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Study design
Allocation
NON_RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes
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 * 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 Inclusion Criteria for Subjects with Non-Cardiac Disease (Objective 4) * Having known brain disease including but not limited to: * Transient ischemic attack or stroke after 24 hours of onset * Infection, inflammation meningitis * Cognitive decline, neurodegenerative disorders * Demyelinating disease, multiple sclerosis * Loss of consciousness, seizures, epilepsy * Brain tumor, metastases, abscess, lesion * Vascular pathology * Headache * Hemorrhage * Trauma * Have known musculoskeletal disease including but not limited to: * Persistent neck pain or radiculopathy * Cancer or tumors of the spine * Congenital abnormalities of the spinal cord or knee * Multiple sclerosis * Injury or trauma * Fracture evaluation * Infectious or inflammatory processes * Soft tissue damage * Muscle or tendon disorders * Knee meniscal disorders * Marrow abnormalities * Mechanical knee symptoms * Vascular conditions * Have known abdominal diseases including but not limited to: * Bowel obstruction * Masses and tumors * Crohns disease * Diffuse liver disease such as hemochromatosis, hemosiderosis, fatty infiltration * Focal hepatic lesions * Cirrhotic liver * Iron content determination * Cystic kidney disease * Vascular abnormalities * Have known lung disease including but not limited to: * Cancer, tumors and masses * Vascular and lymphatic abnormalities * Pulmonary thromboembolic disease * Trauma * Suspected bronchiolitis * Bronchiectasis or pneumonitis * Asthma and other obstructive lung diseases * Pulmonary lymphangioleiomyomatosis * Cystic and interstitial lung diseases such as pulmonary lymphangioleiomyomatosis and cystic fibrosis * Have other known non-cardiovascular disease Inclusion criteria for bronchodilators: \- Only subjects who use bronchodilators routinely or those have undergone previous pulmonary function testing with bronchodilators will be invited to undergo bronchodilator testing during MRI.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 72 months | To determine whether the the low SAR CMR is a feasible alternative to standard CMR |
Secondary
| Measure | Time frame |
|---|---|
| Numerous exploratory secondary endpoints are sought around the listed measurements across MRI systems and disease states | 60 months |
Countries
United States
Contacts
CONTACTAnastasia Tsakirellis, C.R.N.P.
CONTACTMarcus Y Chen, M.D.
PRINCIPAL_INVESTIGATORMarcus Y Chen, M.D.
National Heart, Lung, and Blood Institute (NHLBI)
Outcome results
None listed