Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 02-H-0050 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with cardiovascular diseases | Patients may receive an intravenous injection of gadobutrol (Gadavist) not to exceed 0.2 mmol/kg of Gd per bolus injection and per examination. |
| |
| Healthy Participants | Patients may receive an intravenous injection of gadobutrol (Gadavist) not to exceed 0.2 mmol/kg of Gd per bolus injection and per examination. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Siemens MRI scanner | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Ongoing |
Not provided
Not provided
-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
Not provided
Not provided
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.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Arlene Sirajuddin, M.D. | National Heart, Lung, and Blood Institute (NHLBI) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Suburban Hospital | Bethesda | Maryland | 20814 | United States | ||
| National Institutes of Health Clinical Center, 9000 Rockville Pike |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8005123 | Background | Baer FM, Voth E, Theissen P, Schicha H, Sechtem U. Gradient-echo magnetic resonance imaging during incremental dobutamine infusion for the localization of coronary artery stenoses. Eur Heart J. 1994 Feb;15(2):218-25. doi: 10.1093/oxfordjournals.eurheartj.a060479. | |
| 7850935 | Background | Baer FM, Voth E, Schneider CA, Theissen P, Schicha H, Sechtem U. Comparison of low-dose dobutamine-gradient-echo magnetic resonance imaging and positron emission tomography with [18F]fluorodeoxyglucose in patients with chronic coronary artery disease. A functional and morphological approach to the detection of residual myocardial viability. Circulation. 1995 Feb 15;91(4):1006-15. doi: 10.1161/01.cir.91.4.1006. |
| Label | URL |
|---|---|
| NIH Clinical Center Detailed Web Page | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D009202 | Cardiomyopathies |
| D006330 | Heart Defects, Congenital |
| D002318 | Cardiovascular Diseases |
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D050197 | Atherosclerosis |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D018376 | Cardiovascular Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Bethesda |
| Maryland |
| 20892 |
| United States |
| 8090892 | Background | Baer FM, Voth E, Theissen P, Schneider CA, Schicha H, Sechtem U. Coronary artery disease: findings with GRE MR imaging and Tc-99m-methoxyisobutyl-isonitrile SPECT during simultaneous dobutamine stress. Radiology. 1994 Oct;193(1):203-9. doi: 10.1148/radiology.193.1.8090892. |
| 38778036 | Derived | Fujikura K, Sathya B, Acharya T, Benovoy M, Jacobs M, Sachdev V, Hsu LY, Arai AE. CMR provides comparable measurements of diastolic function as echocardiography. Sci Rep. 2024 May 22;14(1):11658. doi: 10.1038/s41598-024-61992-6. |
| 29514708 | Derived | Ta AD, Hsu LY, Conn HM, Winkler S, Greve AM, Shanbhag SM, Chen MY, Patricia Bandettini W, Arai AE. Fully quantitative pixel-wise analysis of cardiovascular magnetic resonance perfusion improves discrimination of dark rim artifact from perfusion defects associated with epicardial coronary stenosis. J Cardiovasc Magn Reson. 2018 Mar 8;20(1):16. doi: 10.1186/s12968-018-0436-0. |
| 29454767 | Derived | Hsu LY, Jacobs M, Benovoy M, Ta AD, Conn HM, Winkler S, Greve AM, Chen MY, Shanbhag SM, Bandettini WP, Arai AE. Diagnostic Performance of Fully Automated Pixel-Wise Quantitative Myocardial Perfusion Imaging by Cardiovascular Magnetic Resonance. JACC Cardiovasc Imaging. 2018 May;11(5):697-707. doi: 10.1016/j.jcmg.2018.01.005. Epub 2018 Feb 14. |
| 25827180 | Derived | Nielles-Vallespin S, Kellman P, Hsu LY, Arai AE. FLASH proton density imaging for improved surface coil intensity correction in quantitative and semi-quantitative SSFP perfusion cardiovascular magnetic resonance. J Cardiovasc Magn Reson. 2015 Feb 17;17(1):16. doi: 10.1186/s12968-015-0120-6. |
| 24122452 | Derived | Chen MY, Bandettini WP, Shanbhag SM, Vasu S, Booker OJ, Leung SW, Wilson JR, Kellman P, Hsu LY, Lederman RJ, Arai AE. Concordance and diagnostic accuracy of vasodilator stress cardiac MRI and 320-detector row coronary CTA. Int J Cardiovasc Imaging. 2014 Jan;30(1):109-19. doi: 10.1007/s10554-013-0300-0. Epub 2013 Oct 12. |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |