Technical Development of Cardiovascular Magnetic Resonance Imaging

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorNational Heart, Lung, and Blood Institute (NHLBI)

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

3,400 Participants
are grouped into 2 trial groups
Group A: Affected participants
Group B: Healthy participants

Trial outcomes

Primary outcomes

1

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

Time frame
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.

Time frame
1 day

Other outcomes

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