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

NCT03581318 | Recruiting

• 2 other identifiers: 18011818-H-0118
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Normal and Abnormal Cardiovascular Physiology

Keywords

Congenital Heart Defects; Heart Valve Diseases; Chest pain (angina); Heart Failure; Coronary Heart Disease; CABG; CARDIOMYOPATHY; Atherosclerosis; MRI Technology Improvement

Outcome Measures

Primary Outcomes (4)

• Translational development of MRI sequences

  Possible comparison to other studies that subjects may have undergone. Descriptive MRI catalogue of multiple cardiovascular processes Follow-up of outcomes subsequent to the MRI scan in select subject groups Follow-up of changes in diagnosis following the MRI scan in select subject groups

  on going

• Technical development of MRI sequences

  Possible assessments include structure depictions, heart chamber volumes, blood flow velocity, image quality scores, pixelwise and segmental summary scores of parametric maps in the heart. Anatomical imaging may be assessed for non- cardiac applications. Contrast- to-noise, and signal-to-noise measurements may be performed. For novel sequences, comparisons to standard product sequences may be performed.

  on going

• Evaluating the correlation

  Measurements of cardiac chamber size and function, vascular reactivity and perfusion are among the parameters that may be followed with comparison to standard biomarkers of disease and clinical manifestations of disease. Neurologic vascular reactivity, blood volume, resting state connectivity, BOLD signal changes may be compared among healthy subjects, asymptomatic subjects with risk factors, and subjects with disease.

  on going

• Assesment of Gad deposition in the brain

  Assessment of non-contrast MRI findings that are consistent with gadolinium deposition.

  on going

Study Arms (4)

Assessing Gadolinium deposition within the brain in healthy and patient subjects

Both healthy subjects and patient subjects who have previously undergone MRI and received gadolinium.

Child Patient or Healthy Child

Healthy children will be used as controls for children with cardiac disease. Child patient will undergo MRI scans.

Healthy Volunteers

Subjects may be used to test image quality or functionality of MRI sequences; subjects may also be used as controls for adults with cardiac and non-cardiac disease.

Research Patients Cardiac and Non Cardiac

Adults with risk factors for cardiac disease or suspected or known cardiac disease

Eligibility Criteria

• Age: 7 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Primary care clinic

You may qualify if:

• Age \>= 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

You may not qualify if:

• 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
• 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, 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 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-lives) apart.
• Age \>= 7 years
• Subjects with known or suspected cardiovascular disease

Sponsors & Collaborators

• National Institute of Mental Health (NIMH): collaborator
• National Heart, Lung, and Blood Institute (NHLBI): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Publications (2)

• Bandettini WP, Shanbhag SM, Mancini C, Henry JL, Lowery M, Chen MY, Xue H, Kellman P, Campbell-Washburn AE. Evaluation of Myocardial Infarction by Cardiovascular Magnetic Resonance at 0.55-T Compared to 1.5-T. JACC Cardiovasc Imaging. 2021 Sep;14(9):1866-1868. doi: 10.1016/j.jcmg.2021.02.024. Epub 2021 May 19. No abstract available.

  PMID: 34023254 DERIVED

• Bandettini WP, Shanbhag SM, Mancini C, McGuirt DR, Kellman P, Xue H, Henry JL, Lowery M, Thein SL, Chen MY, Campbell-Washburn AE. A comparison of cine CMR imaging at 0.55 T and 1.5 T. J Cardiovasc Magn Reson. 2020 May 18;22(1):37. doi: 10.1186/s12968-020-00618-y.

  PMID: 32423456 DERIVED

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Heart Defects, Congenital; Heart Valve Diseases; Chest Pain; Angina Pectoris; Heart Failure; Coronary Disease; Cardiomyopathies; Atherosclerosis

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Myocardial Ischemia; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases

Study Officials

• W. Patricia Bandettini, M.D.

  National Heart, Lung, and Blood Institute (NHLBI)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer L Henry, R.N.

CONTACT

(301) 827-6720; henryjl@nhlbi.nih.gov

W. Patricia Bandettini, M.D.

CONTACT

(301) 451-3128; ingkanisorn@nih.gov

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2018
• First Posted: July 10, 2018
• Study Start: July 12, 2018
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: July 29, 2026

Record last verified: 2026-04-01

Locations

US (1)