Technical Development of Cardiovascular Magnetic Resonance Imaging

NCT04927429 | Recruiting

• 2 other identifiers: 10000299000299-H
• Study Type: observational
• Target: 3,400
• Locations: 1 country
• Sites: 2

Brief Summary

Background: In the U.S., over 6.5 million people have heart failure. Researchers want to develop new testing methods for cardiovascular problems using magnetic resonance imaging (MRI) to improve the clinical diagnosis and management of people with heart failure. Objective: To develop and test new methods for imaging the heart and blood vessels using MRI. Eligibility: People ages 18 years and older who are having an MRI of their heart or blood vessels. Healthy volunteers are also needed. Design: Participants will be screened with a medical history. Participants will have a physical exam and blood tests. They will have an electrocardiogram (ECG) to measure the heart s electrical activity. Then they will have their scheduled MRI scan. The MRI scanner is a large, hollow tube. Participants will lie on a table that moves in and out of the tube. During the MRI, they may have contrast dye injected through an intravenous line inserted into their arm or hand. ECG may be used to monitor their heartbeat or coordinate pictures with their heartbeat. A flexible belt may be used to monitor their breathing. A finger probe may be used to track their heart rate and/or oxygenation level. Their blood pressure may be measured. Pictures may be taken of their blood vessels, heart, and lungs before, during, and after they get medicine to increase blood flow. They may lie flat and pedal a stress bicycle to increase their heart rate. Participation will last for 5 years. During that time, participants may receive a yearly survey about their health. They may be contacted for an optional follow-up MRI within 2 years of their MRI.

Conditions

Cardiovascular Disease

Keywords

Cardiac; Blood Pressure; HEART RATE; Heart Disease; Heart Failure; Natural History

Outcome Measures

Primary Outcomes (1)

• To evaluate performance of novel pulse sequences for cardiovascular MRI in patients and healthy volunteers of both genders

  Clinical performance of pulse sequences measured as the number of subjects with custom and novel pulse sequences that has provided diagnostic quality image

  1 day

Secondary Outcomes (1)

• Establishing reference values for measurements from custom sequences.

  1 day

Study Arms (2)

Affected participants

Participants with a clinically indicated referral for cardiac MRI

Healthy participants

Healthy individuals of various ethnicities to serve as reference ranges

Eligibility Criteria

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

Study Population

Primary clinical

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): lead
• Medstar Health Research Institute: collaborator

Study Sites (2)

Medstar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

RECRUITING

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Cardiovascular Diseases; Heart Diseases; Heart Failure

Study Officials

• Eric E Morgan, M.D.

  National Heart, Lung, and Blood Institute (NHLBI)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stacian D Awojoodu, C.R.N.P.

CONTACT

(240) 408-0498; stacian.davis@nih.gov

Eric E Morgan, M.D.

CONTACT

(419) 410-7079; eric.morgan2@nih.gov

Study Design

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

Study Record Dates

• First Submitted: June 15, 2021
• First Posted: June 16, 2021
• Study Start: April 8, 2024
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): December 31, 2031
• Last Updated: May 4, 2026

Record last verified: 2026-04-30

Locations

US (2)