Developing new MRI techniques for cardiovascular imaging

Technical and Translational Development of Cardiovascular MRI (CMR)

This study is testing new MRI techniques to see if they can improve heart imaging for both healthy people and those with heart conditions.

Quick facts

• Study type: Observational
• Enrollment: 5000 (estimated)
• Ages: 7 Years to 100 Years
• Sex: All
• Sponsor: National Institutes of Health Clinical Center (CC) (nih)
• Locations: 1 site (Bethesda, Maryland)
• Trial ID: NCT03581318 on ClinicalTrials.gov

What this trial studies

This study aims to enhance cardiovascular imaging through the development and testing of new MRI techniques. It involves scanning both healthy volunteers and patients with known or suspected cardiovascular diseases to improve clinical diagnosis and management. The research will focus on novel MRI methods, including non-contrast and contrast imaging, and will investigate the relationship between cardiovascular diseases and other organ systems. Additionally, the study will assess the prevalence of gadolinium deposits in the brain following MRI procedures.

Who should consider this trial

Good fit: Ideal candidates include healthy individuals aged 7 and older, as well as those with known or suspected cardiovascular disease.

Not a fit: Patients with significant past or chronic cardiovascular conditions or those with MRI-incompatible devices may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved diagnostic capabilities and better management of cardiovascular diseases.

How similar studies have performed: Other studies have shown promise in improving MRI techniques for cardiovascular imaging, but this specific approach is novel in its comprehensive evaluation of both healthy and diseased populations.

Eligibility criteria

* INCLUSION CRITERIA FOR HEALTHY VOLUNTEERS:
* Age greater than or equal to 7 years
* Able to follow instructions and lie still in the MRI scanner
* Currently without known cardiovascular disease
* Able to provide informed consent in writing or provide guardian consent
* Willingness to cooperate with all study procedures and available for scheduled study events

EXCLUSION CRITERIA FOR HEALTHY VOLUNTEERS:

* Important past or chronic medical illness such as major cardiovascular conditions like myocardial infarction, congenital heart disease, and known cardiomyopathy
* Conditions that are thought to make MRI unsafe (that will be determined by filling out a separate form) including:

  * Cardiac pacemaker or implantable defibrillator unless it is labeled safe or conditional for MRI
  * 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 or cochlear implant unless it is labeled safe for MRI
  * Ocular foreign body (e.g. metal shavings)
  * Metal shrapnel or bullet unless cleared by plain x-ray as safe for MRI
  * Any implanted device (e.g. insulin pump, drug infusion device), unless it is labeled safe or conditional for MRI
* eGFR \< 60 mL/min/1.73m\^2 using the 2021 CKD-EPI equation or equivalent and a serum creatinine measured within 2 weeks without intercurrent change in medical condition or medications. Subjects meeting this exclusion criterion may still be included in the study but may not be exposed to gadolinium-based contrast agents
* Pregnancy. When uncertain of pregnancy status, subjects will undergo serum or urine pregnancy testing within the 7 days prior to the examination. Among those subjects who will receive MRI contrast , subjects of child-bearing potential will under serum or urine pregnancy testing within 7 days of the day prior to examination. 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. Post-menopausal and surgically sterilized subjects are automatically exempt from this testing.
* If receiving contrast, children and breast feeding women (unless subject is willing to discard breast milk for 24 hours) are excluded
* Healthy volunteer children will not have contrast
* In a years time, healthy volunteers are not restricted as to the number of non-contrast MRI examinations they undergo, but they may not undergo more than two examinations involving gadolinium-based contrast agents (GBCA) and those exposures will be at least 18 hours (12 half-ives) apart.

INCLUSION CRITERIA FOR SUBJECTS WITH KNOWN OR SUSPECTED WITH HEART DISEASE:

* Age greater than or equal to 7 years
* Subjects with known or suspected cardiovascular disease
* Able to provide informed consent in writing or provide guardian consent
* Willingness to cooperate with all study procedures (including food restriction) and available for scheduled study events

EXCLUSION CRITERIA FOR SUBJECTS WITH KNOWN OR SUSPECTED HEART DISEASE:

* Conditions that are thought to make MRI unsafe (that will be determined by filling out a separate form) including:

  * Cardiac pacemaker or implantable defibrillator unless it is labeled safe or conditional for MRI
  * 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 or cochlear implant unless it is labeled safe for MRI
  * Ocular foreign body (e.g. metal shavings)
  * Metal shrapnel or bullet unless cleared by plain x-ray as safe for MRI
  * Any implanted device (e.g. insulin pump, drug infusion device), unless it is labeled safe or conditional for MRI
* Pregnancy. When uncertain of pregnancy status, subjects will undergo serum or urine pregnancy testing within the 7 days prior to the examination. Among those subjects who will receive MRI contrast , subjects of child-bearing potential will undergo serum or urine pregnancy testing 7 days prior to the examination. 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. Post-menopausal and surgically sterilized subjects are automatically exempt from this testing.
* Breast feeding (unless subject is willing to discard breast milk for 24 hours if receiving contrast)
* eGFR \< 30 mL/min/1.73m\^2 using the 2021 CKD-EPI equation or Community Practice Standard for Pediatric case or equivalent and a serum creatinine measured within 2 weeks without intercurrent change in medical condition or medications. Subjects meeting this exclusion criterion may still be included in the study but may not be exposed to gadolinium-based contrast agents
* Cardiorespiratory instability as determined by the enrolling clinician

INCLUSION CRITERIA FOR SUBJECTS WITH NON-CARDIAC DISEASE:

* Age greater than or equal to 7 years
* Able to provide informed consent in writing or provide guardian consent
* Willingness to cooperate with all study procedures (including food restriction) and available for scheduled study events
* Known or suspected brain, hematology, oncology, endocrine, pulmonary, or other non-cardiac disease.

EXCLUSION CRITERIA FOR SUBJECTS WITH NON- CARDIAC DISEASE:

* Conditions that are thought to make MRI unsafe (that will be determined by filling out a separate screening form) including:

  * Cardiac pacemaker or implantable defibrillator unless it is labeled safe or conditional for MRI
  * 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 or cochlear implant unless it is labeled safe for MRI
  * Ocular foreign body (e.g. metal shavings)
  * Metal shrapnel or bullet unless cleared by plain x-ray as safe for MRI
  * Any implanted device (e.g. insulin pump, drug infusion device), unless it is labeled safe or conditional for MRI
* Pregnancy. When uncertain of pregnancy status, subjects will undergo serum or urine pregnancy testing within the 7 days prior to examination. Among those subjects who will receive MRI contrast , subjects of childbearing potential will undergo serum or urine pregnancy testing on the day of the examination. 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. Post-menopausal and surgically sterilized subjects are automatically exempt from this testing.

* Breast feeding in those subjects receiving contrast (unless subject is willing to discard breast milk for 24 hours
* eGFR \< 30 mL/min/1.73m\^2 using the 2021 CKD-EPI equation14 or equivalent and a serum creatinine measured within 2 weeks without intercurrent change in medical condition or medications. Subjects meeting this exclusion criterion may still be included in the study but may not be exposed to gadolinium-based contrast agents
* Cardiorespiratory instability or as determined by the enrolling clinician

Where this trial is running

Bethesda, Maryland

• National Institutes of Health Clinical Center — Bethesda, Maryland, United States (RECRUITING)

Study contacts

• Principal investigator: W. Patricia Bandettini, M.D. — National Heart, Lung, and Blood Institute (NHLBI)
• Study coordinator: Jennifer L Henry, R.N.

Conditions: Normal and Abnormal Cardiovascular Physiology, Congenital Heart Defects, Heart Valve Diseases, Chest pain, Heart Failure, Coronary Heart Disease, CABG, CARDIOMYOPATHY