Technical Development of Cardiovascular Magnetic Resonance Imaging

Launched by NATIONAL HEART, LUNG, AND BLOOD INSTITUTE (NHLBI) · Jun 15, 2021

Keywords

ClinConnect Summary

This clinical trial is studying new ways to use magnetic resonance imaging (MRI) to better understand and diagnose heart diseases, particularly heart failure, which affects millions of people in the U.S. The researchers aim to improve how doctors can see the heart and blood vessels, which may help in managing cardiovascular conditions more effectively.

To participate in this study, you need to be at least 18 years old and either have a scheduled MRI for a heart-related issue or be a healthy volunteer. Participants will undergo a series of tests, including a physical exam and an ECG, before having their MRI, which involves lying on a table that moves into a large tube. Some participants may receive a contrast dye to enhance the images, and they might also do some light exercise to help the researchers see how the heart responds. The study will last for five years, during which participants will be asked about their health once a year. If you're interested in helping advance heart imaging techniques, this trial might be a good opportunity for you.

Gender

ALL

Eligibility criteria

• * 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