New MRI techniques aim to sharpen heart disease detection
NCT ID NCT04927429
First seen Jun 27, 2026 · Last updated Sep 16, 2026 · Updated 4 times
Summary
This study aims to develop and test new MRI methods for imaging the heart and blood vessels to improve diagnosis and management of heart disease. It will enroll up to 3,400 adults, including both patients with heart conditions and healthy volunteers. Participants will undergo MRI scans with possible contrast dye, stress tests, and follow-up surveys over 5 years.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 3,400 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2024
- Expected to finish
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Dec 2031
An estimate. End dates often move.
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Primary clinical
- Ages
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18 to 100 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
* INCLUSION CRITERIA: Group A: In order to be eligible to participate in this study, an individual must meet all of the following criteria: * Provision of signed and dated informed consent form by subject * Stated willingness to comply with all study procedures and availability for the duration of the study * Male or female, 18 years or older * Subjects undergoing a clinically indicated MRI examination. Examples of medical indications include known or suspected heart failure or cardiomyopathy, chest pain with known or suspected coronary artery disease, unexplained dyspnea, valve disease, known or suspected congenital heart disease, cardiac masses and known or suspected aortic disease, exposure to cardiotoxic drugs, and systemic illnesses with known associated cardiovascular involvement. Group B, Healthy volunteers enrolled for developmental testing and establishing reference values for the custom pulse sequences. In order to be eligible to participate in this study, an individual must meet all of the following criteria: * Provision of signed and dated informed consent form * Stated willingness to comply with all study procedures and availability for the duration of the study * Male or female, 18 years or older EXCLUSION CRITERIA: 1. An individual who meets any of the following criteria will be excluded from participation in this study: * Unable to undergo magnetic resonance imaging because of: * Central nervous system aneurysm clips * Implanted neural stimulator * Implanted cardiac pacemaker or defibrillator * Cochlear implant * Ocular foreign body (e.g. metal shavings) * Implanted Insulin pump * Metal shrapnel or bullet unless any of the above objects have been cleared as safe for MRI according to the assessment present as clinical routine at the site. * 2.For examinations that include contrast injection of GBCA: \-- renal excretory dysfunction, estimated glomerular filtration rate \<= 30 mL/min/1.73m(2) body surface area.(estimated glomerular filtration rate is only determined according to the institutional guidelines of patients at risk of renal dysfunction and may also depend upon the dose of GBCA administered). \-- Known allergic reactions to GBCA \-- Subjects may still be invited for non-contrast enhanced examinations or undergo MR examination with ferumoxytol as contrast agent. . For examinations that include contrast injection of ferumoxytol \-- Known allergic reactions to ferumoxytol or to mannitol excipient * For subjects with a planned pharmacological stress test with adenosine or regadenoson the following contraindications will be considered as exclusion criteria: --Bronchospastic lung disease with ongoing wheezing or history of significant reactive airway disease --Second- or third- degree atrioventricular blood, sinus node disease without a functioning MR conditional pacemaker --Systolic blood pressure \< 90 mmHg --Uncontrolled hypertension (systolic BP \> 200 mmHg or diastolic BP \> 110 mmHg) --Recent (\< 48hr) use of dipyridamole of dipyridamole- containing medications --Known hypersensitivity to adenosine or regadenoson. * Unstable angina, acute coronary syndrome, or less than 2- 4 days after an acute myocardial infarction * For regadenoson only: seizure disorder as regadenoson may lower seizure threshold. Aminophylline should not be used in cases of seizures associated with Regadenoson. * Pregnant Women. * Lactating Women for administration of GBCA unless the subjects is willing to discard the milk for 24 hours after receiving gadolinium In addition, the following exclusion criteria pertains to Group B, healthy volunteers to be considered for reference values: * Known history of major illness, including, but not limited to having a hypertension diagnosis in need of anti-hypertensive medication, myocardial infarction, diabetes, familial hypercholesterolemia, cardiomyopathy, congenital heart disease, moderate or severe valvular disease, cerebrovascular insult or peripheral vascular disease, symptoms of angina or dyspnea, current smoker. * Decisionally impaired individuals
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Medstar Washington Hospital Center
RECRUITINGWashington D.C., District of Columbia, 20010, United States
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National Institutes of Health Clinical Center
RECRUITINGBethesda, Maryland, 20892, United States
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