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Low SAR MRI Scans for Coronary Heart Disease

N/A

Recruiting

Led By Adrienne E Campbell, Ph.D.

Research Sponsored by National Heart, Lung, and Blood Institute (NHLBI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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 (for Subjects with Heart Disease)

Subjects with 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 (for Subjects with Non-Cardiac Disease)

Must not have

Gadolinium based contrast agent (GBCA) exposure is not permitted if eGFR < 60 mL/min/1.73m(2) for Healthy Volunteers, and if eGFR < 30 mL/min/1.73m(2) for Volunteers with Cardiac and Non-Cardiac Disease

Severe chronic obstructive pulmonary disease defined as requiring more than one bronchodilator medication every day or continuous oxygen requiring, prior treatment with bleomycin (for Oxygen Inhalation)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 72 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new, lower-energy MRI scanner to see if it creates better pictures than a conventional MRI. The trial is for people with disease and healthy volunteers, ages 18 and older.

Who is the study for?

This trial is for adults aged 18 and older, both with coronary heart disease and healthy volunteers. Participants must be willing to follow study procedures, including food restrictions, and provide written consent. Those with allergies to certain contrast agents or severe medical conditions making MRI unsafe are excluded.

What is being tested?

Researchers are testing a new low-energy MRI scanner system that could be safer for patients with metal implants. The study involves comparing images from the new scanner against conventional MRIs, possibly using a dye or drug to enhance image quality.

What are the potential side effects?

Potential side effects may include temporary chest pain or shortness of breath from vasodilator drugs used during scans. Allergic reactions to dyes like gadolinium might occur, although rare.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a known heart condition.

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I do not have any known brain conditions or injuries.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not been exposed to a specific contrast agent if my kidney function is below a certain level.

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I have severe COPD and need multiple medications or constant oxygen.

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I refuse to take medication to open my airways.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 72 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~72 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 72 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Group CExperimental Treatment1 Intervention

Group C includes 500 adult subjects of both sexes with known non-cardiovascular disease

Group II: Group BExperimental Treatment1 Intervention

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

Group III: Group AExperimental Treatment2 Interventions

Group A includes 600 healthy adult volunteers of both sexes with-out known cardiovascular disease

0 / 5Eligibility criteria met