Technical Development of Cardiovascular Magnetic Resonance Imaging
- Conditions
- Cardiovascular Disease
- Registration Number
- NCT04927429
- 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 3400
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate performance of novel pulse sequences for cardiovascular MRI in patients and healthy volunteers of both genders 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
- Secondary Outcome Measures
Name Time Method Establishing reference values for measurements from custom sequences. 1 day 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.
Trial Locations
- Locations (2)
National Institutes of Health Clinical Center
🇺🇸Bethesda, Maryland, United States
Medstar Washington Hospital Center
🇺🇸Washington, District of Columbia, United States