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| ID | Type | Description | Link |
|---|---|---|---|
| 07-H-0157 |
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Per IRB recommendation, a separate protocol will be prepared for retrospective data analysis. The current protocol does not have specific hypotheses.
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This study will evaluate volunteers 18 years of age and older to see if they qualify for one of NHLBI s research studies. Tests include the following:
This is a screening protocol. This protocol allows two functions: 1) the protocol allows physicians in the Suburban/NHLBI Cardiovascular Imaging program to evaluate patients referred to the program with clinically indicated studies and research studies. 2) It is also designed to determine if patients may be suitable candidates for one of our NHLBI research protocols.
Patients greater than or equal to 18 years of age referred for possible cardiovascular disease will be enrolled in the protocol for a period of one year. At one year, patients will either be: 1) transferred to one of our specific research MRI or CT protocols, 2) removed from the screening protocol and made inactive, or 3) re-enrolled on the screening protocol with the patient s consent.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with known or suspected cardiovascular disease | Patients referred to protocol with known or suspected cardiovascular disease for further evaluation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Toshiba Aquilion ONE CT | Device | The Toshiba Aquilion ONE CT system has the ability to acquire whole organ volume images in a single rotation by utilizing an x-ray detector that is configured as 320 detector rows with a 0.5 mm width, providing a z-axis coverage of 16 cm of anatomy. |
| Measure | Description | Time Frame |
|---|---|---|
| Complete characterization of patients for screening purpose onto a research protocol. | Complete characterization of patients for the purpose of deciding whether they are eligible for research protocols run by the Cardiovascular Branch. | Ongoing |
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No one will be excluded from this study based on race, gender, or ethnicity.
A. General Inclusion Criteria:
B. General Exclusion Criteria:
Test Specific Exclusion Criteria:
A. CT Exclusion Criteria (excludes contrast enhanced CT scan only):
B. Beta Antagonist Exclusions (excluded the use of beta blocker only):
C. MRI Exclusion Criteria (excludes MRI scan only):
D. Exclusions from MRI contrast agents:
E. Vasodilator Exclusions (excludes some vasodilator stress testing):
F. Exclusions from Dobutamine stress MRI only:
G. Exclusion criteria for atropine (given during dobutamine stress echocardiography when target heart rate not achievable with dobutamine alone).
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Patients > 18 years of age referred for possible cardiovascular disease will be enrolled in the protocol for a period of one year.
At one year, patients will either be: 1) transferred to one of our specific research MRI or CT protocols, 2) removed from the screening protocol and made inactive, or 3) re-enrolled on the screening protocol with the patient's consent.
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| Name | Affiliation | Role |
|---|---|---|
| Andrew E Arai, 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 |
|---|---|---|---|
| 16477061 | Background | Escolar E, Weigold G, Fuisz A, Weissman NJ. New imaging techniques for diagnosing coronary artery disease. CMAJ. 2006 Feb 14;174(4):487-95. doi: 10.1503/cmaj.050925. | |
| 16037533 | Background | White CS, Kuo D, Kelemen M, Jain V, Musk A, Zaidi E, Read K, Sliker C, Prasad R. Chest pain evaluation in the emergency department: can MDCT provide a comprehensive evaluation? AJR Am J Roentgenol. 2005 Aug;185(2):533-40. doi: 10.2214/ajr.185.2.01850533. |
| Label | URL |
|---|---|
| NIH Clinical Center Detailed Web Page | View source |
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| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| D050197 | Atherosclerosis |
| D017202 | Myocardial Ischemia |
| D009203 | Myocardial Infarction |
| D007511 | Ischemia |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| SWiemens 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. |
|
| Bethesda |
| Maryland |
| 20892 |
| United States |
| 17010819 | Background | Hendel RC, Patel MR, Kramer CM, Poon M, Hendel RC, Carr JC, Gerstad NA, Gillam LD, Hodgson JM, Kim RJ, Kramer CM, Lesser JR, Martin ET, Messer JV, Redberg RF, Rubin GD, Rumsfeld JS, Taylor AJ, Weigold WG, Woodard PK, Brindis RG, Hendel RC, Douglas PS, Peterson ED, Wolk MJ, Allen JM, Patel MR; American College of Cardiology Foundation Quality Strategic Directions Committee Appropriateness Criteria Working Group; American College of Radiology; Society of Cardiovascular Computed Tomography; Society for Cardiovascular Magnetic Resonance; American Society of Nuclear Cardiology; North American Society for Cardiac Imaging; Society for Cardiovascular Angiography and Interventions; Society of Interventional Radiology. ACCF/ACR/SCCT/SCMR/ASNC/NASCI/SCAI/SIR 2006 appropriateness criteria for cardiac computed tomography and cardiac magnetic resonance imaging: a report of the American College of Cardiology Foundation Quality Strategic Directions Committee Appropriateness Criteria Working Group, American College of Radiology, Society of Cardiovascular Computed Tomography, Society for Cardiovascular Magnetic Resonance, American Society of Nuclear Cardiology, North American Society for Cardiac Imaging, Society for Cardiovascular Angiography and Interventions, and Society of Interventional Radiology. J Am Coll Cardiol. 2006 Oct 3;48(7):1475-97. doi: 10.1016/j.jacc.2006.07.003. No abstract available. |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |