About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
Central nervous system aneurysm clips
Implanted neural stimulator
Implanted cardiac pacemaker or defibrillator
Cochlear implant
Trial population
Primary clinical
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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
Secondary outcomes
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.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
National Heart, Lung, and Blood Institute (NHLBI)
Lead sponsor
Medstar Health Research Institute
Collaborator