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Recruiting
NCT04927429
Technical Development of Cardiovascular Magnetic Resonance Imaging
Conditions: Cardiovascular Disease
Sex: All
Ages: 18 Years – 100 Years
Healthy volunteers: Yes
Enrollment: 3400
Sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Location: Medstar Washington Hospital Center Washington D.C. District of Columbia
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.
Eligibility Criteria
* 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, 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.
Group B, Healthy volunteers enrolled for developmental testing and establishing reference values for the custom pulse sequences. 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
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Male or female, 18 years or older
EXCLUSION CRITERIA:
1. An individual who meets any of the following criteria will be excluded from participation in this study:
* Unable to undergo magnetic resonance imaging because of:
* Central nervous system aneurysm clips
* Implanted neural stimulator
* Implanted cardiac pacemaker or defibrillator
* Cochlear implant
* Ocular foreign body (e.g. metal shavings)
* Implanted Insulin pump
* Metal shrapnel or bullet
unless any of the above objects have been cleared as safe for MRI according to the assessment present as clinical routine at the site.
* 2.For examinations that include contrast injection of GBCA:
\-- renal excretory dysfunction, estimated glomerular filtration rate \ 200 mmHg or diastolic BP \> 110 mmHg)
--Recent (\< 48hr) use of dipyridamole of dipyridamole- containing medications
--Known hypersensitivity to adenosine or regadenoson.
* Unstable angina, acute coronary syndrome, or less than 2- 4 days after an acute myocardial infarction
* For regadenoson only: seizure disorder as regadenoson may lower seizure threshold. Aminophylline should not be used in cases of seizures associated with Regadenoson.
* Pregnant Women.
* Lactating Women for administration of GBCA unless the subjects is willing to discard the milk for 24 hours after receiving gadolinium
In addition, the following exclusion criteria pertains to Group B, healthy volunteers to be considered for reference values:
* Known history of major illness, including, but not limited to having a hypertension diagnosis in need of anti-hypertensive medication, myocardial infarction, diabetes, familial hypercholesterolemia, cardiomyopathy, congenital heart disease, moderate or severe valvular disease, cerebrovascular insult or peripheral vascular disease, symptoms of angina or dyspnea, current smoker.
* Decisionally impaired individuals
Source: ClinicalTrials.gov (NCT04927429). StuddyBuddy aggregates publicly available trial information.