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

  • STATUS
    Recruiting
  • End date
    May 31, 2024
  • participants needed
    2100
  • sponsor
    National Heart, Lung, and Blood Institute (NHLBI)
Updated on 17 June 2022
cardiovascular disease
cancer
chest pain
stroke
ejection fraction
heart disease
myocardial infarction
angina pectoris
infarct
stable angina
vasodilator
Accepts healthy volunteers

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

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 images with higher signal-to-noise ratio (SNR). We have proposed a method of CMR, requiring custom scanner hardware, that can be performed with low SAR but that nevertheless preserves SNR because of more efficient use of NMR 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.

Details
Condition CAD
Treatment MRI scan, MRI Scans, MRI scan x 1- Healthy volunteer, MRI scan x 2- Healthy volunteer, MRI scan x 2- CAD patients, MRI scan x 2- non-CAD patients, MRI scan x 2- cardiac disease patients, MRI scan x 2- patients with non-cardiac disease, MRI scan x 1 Healthy Volunteer, MRI scan x 2 Healthy Volunteer, MRI scan x 2 - CAD patients, MRI scan x 2- non CAD patients, MRI scan - obj 1, MRI scans - obj 2, MRI scans - obj 3, MRI scans - obj 4
Clinical Study IdentifierNCT03331380
SponsorNational Heart, Lung, and Blood Institute (NHLBI)
Last Modified on17 June 2022

Eligibility

Yes No Not Sure

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

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
If a urine or serum pregnancy test was administered as part of a referral protocol, and the test was administered up to 7 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 7 days of MRI examination for this protocol, a serum pregnancy test will be administered if a subject is currently undergoing bloodwork for other tests. If a subject is currently not undergoing any bloodwork, a urine pregnancy test will be administered. 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
Pregnancy. When uncertain, subjects will undergo either urine or serum pregnancy
Exclusion Criteria for Gadolinium
testing. Results from up to 7 days prior to the examination will be used
When gadolinium based contrast agent (GBCA) exposure is planned
Post-menopausal and surgically sterilized subjects are exempt from this
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
testing
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 CKD-EPI 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
Subjects meeting this exclusion criterion, or without eGFR determination, may still be included in the study but may not be exposed to gadolinium-based contrast agents
Breast feeding (unless subject is willing to discard breast milk for 24 hours)
Exclusion Criteria for Oxygen Inhalation
Severe chronic obstructive pulmonary disease defined as requiring more than one bronchodilator medication every day or continuous oxygen requiring
Prior treatment with bleomycin
Exclusion Criteria for Ferumoxytol Contrast
Exclusion Criteria for Healthy Volunteers (Objectives 1 and 2)
A history of allergic reaction to any intravenous iron product
Important past medical illness
Allergy to ferumoxytol or to mannitol excipient
Breast feeding (unless subject is willing to discard breast milk for 24 hours)
Does not wish to be exposed to ferumoxytol
Exclusion Criteria for Adults with heart Disease (Objective 3)
Unstable angina, acute coronary syndrome, or myocardial infarction not attributable to PCI, within 2 weeks unless after coronary revascularization of the culprit lesion
Any hemodynamic instability or decompensated heart failure as determined by the enrolling physician
Exclusion Criteria for oral contrast agent
Patients with asthma or chronic obstructive pulmonary disease are ineligible for vasodilator stress CMR
A history of reaction to oral contrast (if using barium sulfate)
Patients with advanced heart block on baseline ECG are ineligible for vasodilator stress CMR
Breast feeding unless subject is willing to discard breast milk for 24 hours (if using barium sulfate)
Exclusion Criteria for Adults with Non-Cardiac Disease (Objective 4)
Allergy to pineapple (ig using pineapple juice)
Acute illness for which investigational imaging might delay care (such as acute stroke before treatment), as determined by the enrolling physician
Does not wish to be exposed to oral contrast
Any hemodynamic instability as determined by the enrolling physician
Low-SAR MRI
Conventional MRI
Subjects with CIEDs are excluded if they have pacemakers implanted before 1998; ICDs
<4 weeks prior to MRI exam
Exclusion criteria for bronchodilators
Inability to withhold bronchodilators for 24 hours prior to MRI exam
Exclusion criteria for adults with cardiac implanted electronic devices (CIED, pacemakers
or defibrillators
Subjects with MRI-conoditional and legacy CIEDs are not excluded, based on the
intrinsic safety of low-SAR MRI
implanted before 2000; temporary, epicardial or abandoned leads; and CIEDs implanted
Subjects with CIED are excluded from conventional MRI unless they have CIEDs that are
labeled as MRI conditional or MRI safe, and that are implanted greater than or equal to 4
weeks prior to MRI
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