Cardiovascular DiseaseNCT04927429
Technical Development of Cardiovascular Magnetic Resonance Imaging
An observational study of Cardiovascular Disease, run by National Heart, Lung, and Blood Institute (NHLBI) at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease
- How many people
- 3,400 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 Apr 2024to 31 Dec 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Primary clinical
Who may be able to join
- 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:
Show all 9Show fewer
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR), 800-411-1222 ext. TTY8664111010, prpl@cc.nih.gov
- Recruiting
Medstar Washington Hospital Center
Washington D.C., District of Columbia, 20010
James H. Boscoe, MA, CIP, 301-560-2912, MHRI-ORIHelpDesk@medstar.net
About this study
Official title: Technical Development of Cardiovascular MRI
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.
Read more
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.
Read the detailed description
Study Desccription: This protocol allows testing of novel research pulse sequences in investigational cardiovascular magnetic resonance imaging (MRI) and allows application of custom pulse sequences that are not market-cleared in routine clinical MRI.
Objectives: To evaluate performance of novel pulse sequences for cardiovascular MRI in patients and healthy volunteers.
To provide a regulatory framework (abbreviated IDE) to implement and test custom pulse sequences (a non-significant risk medical device) in patients with cardiovascular disease.
Endpoints:
Primary Endpoint : Successful clinical performance of pulse sequences measured as the number of subjects with custom and novel pulse sequences that has provided diagnostic quality image.
Secondary Endpoint: Reference values in healthy volunteers for measurements of myocardial perfusion, T1, T2, and extracellular volume from custom pulse sequences.
Exploratory endpoints:
- Differences in perfusion, function, infarction, extracellular volume, T1, T2 and T2*, flow with heart disease etiology, treatment and functional class of disease as well as age, sex, race and correlations between these parameters.
- Relationship with clinical markers such as prognostic influence and change in patient management based on findings from MRI examination including the custom pulse sequences may be explored.
- Comparisons to the results from novel and custom sequences to standard product sequences provided by the vendor may be performed.
- To investigate the relationship between cardiac MRI biomarkers and blood biomarkers of heart disease in order to understand the disease process and enable a deep phenotyping of heart failure.
- Conditions
- Cardiovascular Disease
- Keywords
- Cardiac, Blood Pressure, HEART RATE, Heart Disease, Heart Failure, Natural History
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Affected participants | Participants with a clinically indicated referral for cardiac MRI | |
| Healthy participants | Healthy individuals of various ethnicities to serve as reference ranges |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 day
Secondary outcomes (1)
Establishing reference values for measurements from custom sequences.
Reference values in healthy volunteers for measurements of heart filling and emptying measures, myocardial perfusion, T1, T2, T2* and extracellular volume from custom pulse sequences.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2021
- Study start8 Apr 2024
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,400 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Medstar Health Research Institute
- Responsible party
- Sponsor
- Investigators
- Eric E Morgan, M.D., Principal investigator, National Heart, Lung, and Blood Institute (NHLBI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04927429
- Sponsor's protocol ID
- 10000299
- Other IDs
- 000299-H
- Status last verified
- 7 Oct 2026
- First submitted
- 15 Jun 2021
- Last updated
- 9 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Technical Development of Cardiovascular MRI
- ClinicalTrials.gov ID
- NCT04927429
- Acronym / sponsor ID
- 10000299
- Conditions
- Cardiovascular Disease
- Keywords
- Cardiac, Blood Pressure, HEART RATE, Heart Disease, Heart Failure, Natural History
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,400 participants (estimated)
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Collaborators
- Medstar Health Research Institute
- Study start
- 8 Apr 2024 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 16 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study Desccription: This protocol allows testing of novel research pulse sequences in investigational cardiovascular magnetic resonance imaging (MRI) and allows application of custom pulse sequences that are not market-cleared in routine clinical MRI.
Objectives: To evaluate performance of novel pulse sequences for cardiovascular MRI in patients and healthy volunteers.
To provide a regulatory framework (abbreviated IDE) to implement and test custom pulse sequences (a non-significant risk medical device) in patients with cardiovascular disease.
Endpoints:
Primary Endpoint : Successful clinical performance of pulse sequences measured as the number of subjects with custom and novel pulse sequences that has provided diagnostic quality image.
Secondary Endpoint: Reference values in healthy volunteers for measurements of myocardial perfusion, T1, T2, and extracellular volume from custom pulse sequences.
Exploratory endpoints:
- Differences in perfusion, function, infarction, extracellular volume, T1, T2 and T2*, flow with heart disease etiology, treatment and functional class of disease as well as age, sex, race and correlations between these parameters.
- Relationship with clinical markers such as prognostic influence and change in patient management based on findings from MRI examination including the custom pulse sequences may be explored.
- Comparisons to the results from novel and custom sequences to standard product sequences provided by the vendor may be performed.
- To investigate the relationship between cardiac MRI biomarkers and blood biomarkers of heart disease in order to understand the disease process and enable a deep phenotyping of heart failure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Affected participants | – | –Participants with a clinically indicated referral for cardiac MRI |
| Healthy participants | – | –Healthy individuals of various ethnicities to serve as reference ranges |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Primary clinical
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (30 listed)
- An individual who meets any of the following criteria will be excluded from participation in this study:
- unless any of the above objects have been cleared as safe for MRI according to the assessment present as clinical routine at the site.
- -- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To evaluate performance of novel pulse sequences for cardiovascular MRI in patients and healthy volunteers of both genders
Time frame: 1 day
Clinical performance of pulse sequences measured as the number of subjects with custom and novel pulse sequences that has provided diagnostic quality image
1 secondary outcome
Establishing reference values for measurements from custom sequences.
Time frame: 1 day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eric E Morgan, M.D. principal investigator
National Heart, Lung, and Blood Institute (NHLBI)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Disease, run by National Heart, Lung, and Blood Institute (NHLBI) at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stacian D Awojoodu, C.R.N.P. ((240) 408-0498, stacian.davis@nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate performance of novel pulse sequences for cardiovascular MRI in patients and healthy volunteers of both genders (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.