An observational study in Cardiomyopathy, Congenital Heart Disease and Cardiovascular Disease, sponsored by National Heart, Lung, and Blood Institute (NHLBI). Completed at 2 sites in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2021-03-30.
Sponsored by National Heart, Lung, and Blood Institute (NHLBI) · Observational
This study will explore new ways of using magnetic resonance imaging (MRI) to evaluate the heart and blood vessels of patients with cardiovascular disease, including better detection of myocardial infarction (heart attack) and blockage of heart and leg arteries.
Patients 18 years of age and older with cardiovascular disease may be eligible for this study.
All participants will have magnetic resonance imaging of the heart. MRI uses a magnetic field and radio waves to show structural and chemical changes in tissues. For the procedure, the patient lies on a table surrounded by a metal cylinder (the scanner). A 'gadolinium contrast' material may be injected into the patient s vein during part of the study to brighten the images. Patients wear earplugs during the scan to muffle loud knocking sounds caused by the electrical switching of the magnetic fields. They will be asked to hold their breath intermittently for 5 to 20 seconds during the scan. They will be monitored with an electrocardiogram (EKG) during the procedure and will be in contact by intercom at all times with the person performing the scan. Patients can request to stop the study and come out of the scanner at any time. The procedure may last from 30 to 90 minutes. An echocardiogram a test that uses sound waves to produce pictures of the heart and blood vessels-may be done to confirm the MRI findings. In addition, patients may undergo one or more of the following optional studies:
The purpose of this protocol is to allow development and testing of new MRI techniques suitable for evaluating patients with cardiovascular disease. Since such technical development work often depends on preliminary studies in healthy volunteers, the protocol also recruits healthy subjects. This protocol will provide the framework for technical development scans in patients with cardiovascular disease.
1,182 studies on the registry are indexed under Cardiomyopathies; 286 are open to participants now.
This study's enrollment of 8,781 is above the median of 153 across 519 observational studies indexed under Cardiomyopathies.
Browse Cardiomyopathies studies →National Heart, Lung, and Blood Institute (NHLBI) is the lead sponsor of 1,143 studies on the registry; 72 are open to participants now.
Of its 58 completed or terminated interventional studies of FDA-regulated products, 50 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients with cardiovascular diseases and healthy subjects 18 years of age or older were recruited within this protocol. The exclusion criteria were developed from standard clinical practice but were more restrictive to err on the side of safety. Recruitment was via referral from local physicians. In addition, advertisements were placed in the "Washington Post". Finally, the protocol was listed on the NIH websites.
A patient could participate in any combination of these tests/procedures. Clinical judgment was used to determine the number of tests/procedures suitable for a given patient. Specifically, the responsible physician avoided prolonging tests/procedures in patients in accordance with the patient's clinical status.
-INCLUSION CRITERIA:
Inclusion Criteria for All Arms of the Protocol:
EXCLUSION CRITERIA:
Exclusion Criteria for All Arms of the Protocol:
Patients with a contraindication to MRI scanning will be excluded. These contraindications include patients with the following devices:
In addition, the following patient groups will be excluded:
Furthermore, the following patient groups will be excluded from studies involving the administration of MRI contrast agents:
The eGFR will be used to estimate renal function if reported by the laboratory, or as reported by NIH Clinical Center or Suburban Hospital or other clinically certified laboratories. Otherwise, estimated glomerular filtration rate (eGFR) can be based on the Modification of Diet in Renal Disease (MDRD) study equation (see below) in subjects with stable renal function. This formula is not applicable to patients with acute renal insufficiency:
eGFR (ml/min/1.73 m(2)) equal to 175 times (serum creatinine)-1.154 times (age)-0.203 times 0.742 (if the subject is female) times1.212 (if the subject is black)
Additional Exclusion Criteria for Dobutamine, or Vasodilator Stress MRI:
Additional Exclusion Criteria for PET/MR perfusion scans
Patients may receive an intravenous injection of gadobutrol (Gadavist) not to exceed 0.2 mmol/kg of Gd per bolus injection and per examination.
Device: Siemens MRI scanner
Patients may receive an intravenous injection of gadobutrol (Gadavist) not to exceed 0.2 mmol/kg of Gd per bolus injection and per examination.
Device: Siemens MRI scanner
Investigational or research MRI coils may be used in the protocol. The coils are noninvasive devices external to the body. The coils act as antennae to receive small radiofrequency signals out of the body. Coils of the type we use are used daily in clinical MRI practice.
examine the rate of major cardiovascular events (MACE) defined as cardiac death, non- fatal myocardial infarction, cerebrovascular / transient ischemic attack, and revascularization in patients undergoing stress or rest cardiac MRI
examine the rate of major cardiovascular events (MACE) defined as cardiac death, non- fatal myocardial infarction, cerebrovascular / transient ischemic attack, and revascularization in patients undergoing stress or rest cardiac MRI and to relate these events to the extent of ischemia and infarction seen on the MRI exams
Time frame: Ongoing
This study is completed, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.
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