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Technical and Translational Development of Cardiovascular Magnetic Resonance (CMR) Imaging

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ClinicalTrials.gov Identifier: NCT03581318
Recruitment Status : Recruiting
First Posted : July 10, 2018
Last Update Posted : October 18, 2018
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )

Brief Summary:

Background:

Magnetic resonance imaging (MRI) is an important non-invasive tool to study and diagnose cardiovascular disease. MRI scanners use strong magnetic fields and radio waves to create pictures of body organs. Researchers want to find better MRI methods and new ways of imaging cardiovascular disease and better understand normal and abnormal cardiovascular and brain function. Researchers are also interested in seeing if gadolinium, the commonly used MRI contrast agent, stays in the body long after the MRI was performed.

Objectives:

To develop new methods for imaging the heart and other organs of the body.

To describe cardiovascular diseases using newer MRI methods

To look at the relationship between cardiovascular disease and cardiovascular risk factors and other organ systems

To look for gadolinium deposits in the brain from prior exams.

Eligibility:

Healthy people and people with known or suspected cardiovascular disease ages 7 and older may be eligible for this study.

Researchers may be particularly interested in those who:

  • Have suspected or known cardiovascular disease
  • Were previously exposed to a gadolinium-based contrast agent,
  • Need to have a heart MRI scheduled
  • Need a test of the heart or other body part or will be undergoing a future cardiac catheterization

Design:

There are multiple arms to the study with optional components; therefore, there are multiple variations as to what an individual participant s experience may involve.

Participants will have an MRI scan lasting up to 2 hours. The scanner is a large hollow tube. During the scan, there may be loud knocking and buzzing sounds caused by the scanner. Participants will lie on a table that slides in and out of the tube. Their vital signs may be monitored.

Participants may have a test of heart electrical activity using wires connected to pads on the skin.

Participants may have blood drawn.

Participants may be injected with an MRI contrast agent through a plastic tube inserted in the arm.


Condition or disease
Cardiac Disease

Detailed Description:

The purpose of this protocol is to develop and test new MRI techniques applicable to patients undergoing cardiovascular evaluation with the ultimate goal of translating the technical advances into improving clinical diagnosis and management of patients undergoing cardiovascular evaluation. Patients undergoing cardiovascular evaluation and healthy volunteers will be scanned under the protocol. We will evaluate new developments in non-contrast and contrast MRI of the heart and blood vessels and novel postprocessing methods.

The use of the newer sequences will be used to improve clinical imaging workflow and disease diagnosis. We hope to use this protocol to clearly describe cardiovascular disease and associated problems using novel MRI methods and follow certain subsets of patients with disease as part of a natural history process. Inter-related physiologic systems may be phenotyped by MRI with characterization of disease associations between different organ systems.

Additionally, information regarding gadolinium deposition of the brain will be gathered. The literature regarding deposition of gadolinium in the brain has a large void regarding information of prevalence of the phenomenon in healthy subjects. The National Institutes of Health has a large healthy subject pool who have participated in gadolinium contrast MRI studies. This pool of healthy subjects is not easily available at most clinical MRI centers, and thus, we are uniquely well-situated to be able to answer this outstanding question.

For all objectives, MRI studies will be conducted in the NIH MRI systems located at the NIH Clinical Center in Bethesda, Maryland. These procedures may involve the intravenous administration of commercially available MR contrast media and exercise or pharmacologic stress testing. Results will be used to evaluate the performance of various research pulse sequences, gradient coils, and radiofrequency receiver coils on human subjects and will provide essential ground work for specific patient protocols, both diagnostic and therapeutic.


Study Type : Observational
Estimated Enrollment : 9999 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Technical and Translational Development of Cardiovascular Magnetic Resonance (CMR) Imaging
Actual Study Start Date : July 12, 2018
Estimated Primary Completion Date : April 1, 2028
Estimated Study Completion Date : April 1, 2028

Group/Cohort
Healthy adults
Subjects will be used as controls for adults with cardiac disease
Adults with cardiac disease
Subjects will undergo MRI scans
Healthy children
Healthy children will be used as controls for children with cardiac disease
Children with cardiac disease
Subjects will undergo MRI scans



Primary Outcome Measures :
  1. Comparison of MRI measurements and examinations obtained using research sequences versus commercial MRI sequences sequences in healthy volunteers and in patients with disease [ Time Frame: ongoing ]
    Prospective study of MRI methods and uses



Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 99 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Primary clinical
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 medical illness
  • 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 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 on the day of examination. Among those subjects who will receive MRI contrast , subjects of child-bearing potential will under serum or urine pregnancy testing on the day of the examination. 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
  • In a year s 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 on the day of examination. Among those subjects who will receive MRI contrast , subjects of child-bearing potential will undergo serum or urine pregnancy testing on the day of the examination. 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 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
  • 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 on the day of examination. Among those subjects who will receive MRI contrast , subjects of child-bearing potential will undergo serum or urine pregnancy testing on the day of the examination. 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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03581318


Contacts
Contact: W. Patricia Bandettini, M.D. (301) 496-3658 ingkanisorn@nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)    800-411-1222 ext TTY8664111010    prpl@cc.nih.gov   
Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: W. Patricia Bandettini, M.D. National Heart, Lung, and Blood Institute (NHLBI)

Additional Information:
Responsible Party: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT03581318     History of Changes
Other Study ID Numbers: 180118
18-H-0118
First Posted: July 10, 2018    Key Record Dates
Last Update Posted: October 18, 2018
Last Verified: October 4, 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) ):
MRI Technology Improvement

Additional relevant MeSH terms:
Heart Diseases
Cardiovascular Diseases