Technical Development of Cardiovascular MRI
National Heart, Lung, and Blood Institute (NHLBI)
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.
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 clini…
Eligibility
- Age range
- 18–100 years
- Sex
- All
- Healthy volunteers
- Yes
* INCLUSION CRITERIA: 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, kno…
Locations (2)
- Medstar Washington Hospital CenterWashington D.C., District of Columbia
- National Institutes of Health Clinical CenterBethesda, Maryland