Actively Recruiting

Phase Not Applicable
Age: 18Years - 100Years
All Genders
Healthy Volunteers
ID03331380

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

Led by National Heart, Lung, and Blood Institute (NHLBI) · Updated on 2026-06-08

2950

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating a new type of magnetic resonance imaging (MRI) scanner that uses lower energy levels, known as low specific absorption rate (SAR) cardiovascular magnetic resonance imaging (CMR). This method aims to produce high-quality images while potentially reducing heating of metal implants, allowing safer scanning for people with metallic devices or during invasive heart procedures. The study includes healthy volunteers and adult patients with heart or other diseases to test the new scanner's technical feasibility and accuracy compared to conventional MRI. Participants fall into three groups: healthy adults without cardiovascular disease, adults with stable heart disease (such as coronary artery disease, heart failure, or valvular disease), and adults with non-cardiovascular diseases like neurological or musculoskeletal conditions. Depending on the group and study objective, participants undergo either one or two MRI scans using the new low SAR system and conventional MRI scanners, sometimes with a contrast dye called gadolinium and possibly a vasodilator drug to assess heart blood supply. Scans can last up to two hours, with breath holds and heart and breathing monitoring during imaging. During the study, participants will have blood tests and various MRI scans within 60 days if two scans are done. Some may receive gadolinium contrast or vasodilator drugs with monitoring for side effects. Researchers will measure image quality and compare the accuracy of the new scanner to standard MRI in healthy volunteers and patients. The study includes follow-up for up to 72 months to assess the technical performance and diagnostic accuracy of the low SAR MRI system. Participants must cooperate with study procedures and attend scheduled visits throughout the study period.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 100Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Men and women age 18 years or older
  • Able to provide written informed consent
  • Willing to cooperate with all study procedures and attend scheduled study events
  • Currently healthy individuals for objectives 1 and 2
  • Adults with known stable heart disease for objective 3, including stable angina, past myocardial infarction, heart failure with reduced ejection fraction, valvular heart disease, pulmonary hypertension, congenital heart disease, myocarditis, infiltrative and hypertrophic cardiomyopathies
  • Adults with known non-cardiovascular disease for objective 4, including brain, musculoskeletal, abdominal, or lung diseases as specified
  • Subjects using bronchodilators routinely or who have undergone pulmonary function testing with bronchodilators may be invited to bronchodilator testing during MRI
Not Eligible

You will not qualify if you...

  • Conditions making MRI unsafe, including cerebral aneurysm clips, neural stimulators, ear implants, ocular foreign bodies, metal shrapnel or bullets, implanted devices not labeled safe for MRI
  • Pregnancy or uncertain pregnancy without appropriate testing
  • Kidney function (eGFR) below specified limits for gadolinium contrast use
  • Breastfeeding unless willing to discard milk for 24 hours if contrast agents are used
  • Refusal to be exposed to gadolinium or other contrast agents
  • Severe chronic obstructive pulmonary disease requiring multiple daily bronchodilators or continuous oxygen
  • Prior treatment with bleomycin
  • Allergic reactions to intravenous iron products or ferumoxytol
  • Important past medical illness in healthy volunteers
  • Unstable angina, recent acute coronary syndrome or myocardial infarction within 2 weeks unless treated
  • Hemodynamic instability or decompensated heart failure
  • Asthma or COPD excluding vasodilator stress CMR with adenosine or regadenoson as specified
  • Advanced heart block on ECG
  • Acute illness delaying care in non-cardiac disease group
  • Refusal of bronchodilator administration
  • Cardiac implanted devices not meeting safety criteria for MRI as specified

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Up to 2 hours per imaging session

Participants undergo cardiovascular magnetic resonance imaging (CMR) scans using an investigational low specific absorption rate (SAR) scanner and a conventional MRI scanner to compare imaging quality and measurements across devices. This includes healthy volunteers and patients with stable cardiovascular or non-cardiovascular diseases.

2 visits (in-person) for comparative MRI scans

Long-term Monitoring

Duration - Up to 72 months

Participants are observed for technical feasibility and accuracy of low SAR CMR imaging compared to conventional imaging over the study period.

Additional visits may occur depending on participant group and study assessments

Trial Site Locations

Total: 1 location

1

National Institutes of Health Clinical Center

Bethesda, Maryland, United States, 20892

Actively Recruiting

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Research Team

A

Anastasia Tsakirellis, C.R.N.P.

A

Adrienne E Campbell, Ph.D.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

FACTORIAL

Primary Purpose

DIAGNOSTIC

Number of Arms

3

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Published Research Related To This Trial

Evaluation of Myocardial Infarction by Cardiovascular Magnetic Resonance at 0.55-T Compared to 1.5-T.

W Patricia Bandettini, Sujata M Shanbhag, Christine Mancini...

https://pubmed.ncbi.nlm.nih.gov/34023254