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 : November 21, 2022
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Tracking Information | |||||||||
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First Submitted Date ICMJE | July 3, 2018 | ||||||||
First Posted Date ICMJE | July 10, 2018 | ||||||||
Last Update Posted Date | November 21, 2022 | ||||||||
Actual Study Start Date ICMJE | July 12, 2018 | ||||||||
Estimated Primary Completion Date | April 1, 2028 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
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
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Change History | |||||||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Technical and Translational Development of Cardiovascular Magnetic Resonance (CMR) Imaging | ||||||||
Official Title ICMJE | Technical and Translational Development of Cardiovascular MRI (CMR) | ||||||||
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:
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. |
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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 post-processing 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. |
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Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Not Applicable | ||||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Diagnostic |
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Condition ICMJE | Normal and Abnormal Cardiovascular Physiology | ||||||||
Intervention ICMJE | Device: MRI
MRI for up to two hours, some without- and some with- administration of intravenous gadolinium based contrast agents (GBCAs), as well as some without and some with pharmacologic or physical stress.
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Study Arms ICMJE | 1
MRI
Intervention: Device: MRI
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
5000 | ||||||||
Original Estimated Enrollment ICMJE |
9999 | ||||||||
Estimated Study Completion Date ICMJE | April 1, 2028 | ||||||||
Estimated Primary Completion Date | April 1, 2028 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE |
EXCLUSION CRITERIA FOR HEALTHY VOLUNTEERS:
INCLUSION CRITERIA FOR SUBJECTS WITH KNOWN OR SUSPECTED WITH HEART DISEASE:
EXCLUSION CRITERIA FOR SUBJECTS WITH KNOWN OR SUSPECTED HEART DISEASE:
INCLUSION CRITERIA FOR SUBJECTS WITH NON-CARDIAC DISEASE:
EXCLUSION CRITERIA FOR SUBJECTS WITH NON- CARDIAC DISEASE:
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.
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Sex/Gender ICMJE |
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Ages ICMJE | 7 Years and older (Child, Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | Yes | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||||||
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Administrative Information | |||||||||
NCT Number ICMJE | NCT03581318 | ||||||||
Other Study ID Numbers ICMJE | 180118 18-H-0118 |
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Has Data Monitoring Committee | Not Provided | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) ) | ||||||||
Original Responsible Party | Same as current | ||||||||
Current Study Sponsor ICMJE | National Heart, Lung, and Blood Institute (NHLBI) | ||||||||
Original Study Sponsor ICMJE | Same as current | ||||||||
Collaborators ICMJE | National Institute of Mental Health (NIMH) | ||||||||
Investigators ICMJE |
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PRS Account | National Institutes of Health Clinical Center (CC) | ||||||||
Verification Date | November 17, 2022 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |