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This is a prospective, randomized multicenter trial comparing MSCT to standard of care (SOC) diagnostic treatment in the triage of Emergency Department (ED) low to intermediate risk chest pain patients. Our hypotheses are that compared to SOC treatment, MSCT is equally safe and diagnostically effective, as well as more time and cost efficient.
Computed tomography (CT) or "cat scan" is an x-ray test routinely used for diagnostic purposes. Heart ("Cardiac") CT, using the newest scanners, is an improved way of looking at the coronary arteries, which supply blood to the heart muscle. If these arteries are clogged this may cause chest pain or even a heart attack. The images of the coronary arteries obtained by CT scanners (during a 5-10 minute procedure) have been shown by many studies to be accurate, when compared to the conventional invasive cardiac catheterization procedure. In addition, at least five prior studies done at different hospitals suggest that cardiac CT scans are effective for diagnosing chest pain like yours in patients coming to the emergency room. What is new about this study is that it is being done in multiple hospitals at the same time. This is part of the process that all medical advances must go through to become a part of routine care of patients in hospitals throughout the country.
A standard chest pain workup typically done in the emergency department consists of a physical examination, electrocardiograms (EKGs), and several blood tests. Blood tests typically completed include cardiac enzymes (Troponin, CK & CK-MB), a kidney function test, a pregnancy test if applicable, and possibly a lipid panel, depending on physician preference. For each test, a 3mL vial will be filled with a specimen of blood and processed in the laboratory for result. Also a two-part "rest-stress" nuclear scan is typically performed, which compares blood flow into the heart tissue at rest to blood flow into the heart tissue during exercise or dilation with medications. Based on prior studies, the researchers doing the present study believe that CT scanning of the coronary arteries can provide information that is just as safe and accurate as the rest-stress nuclear scan, and can do so more rapidly at a lower cost.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multi-slice Computed Tomography | Active Comparator | Patients admitted to the ED with chest pain and/or anginal equivalent symptoms are randomized to a multi-slice computed tomography arm where they will receive a CT scan of their heart. |
|
| Standard of Care | Active Comparator | Patients admitted to the ED with chest pain and/or anginal equivalent symptoms are randomized to the Standard of Care arm and receive rest-stress nuclear myocardial perfusion imaging test. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multi-slice computed tomography | Procedure | Patient receives a CT scan (multi-slice computed tomography) of the heart. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic efficiency from the time to diagnosis and cost of diagosis for the CCTA and the Standard of Care | Time to diagnosis |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gilbert Raff, MD | Corewell Health East | Study Director |
| Kavitha Chinnaiyan, MD | Corewell Health East | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | United States | ||
| Washington Hospital Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21939822 | Derived | Goldstein JA, Chinnaiyan KM, Abidov A, Achenbach S, Berman DS, Hayes SW, Hoffmann U, Lesser JR, Mikati IA, O'Neil BJ, Shaw LJ, Shen MY, Valeti US, Raff GL; CT-STAT Investigators. The CT-STAT (Coronary Computed Tomographic Angiography for Systematic Triage of Acute Chest Pain Patients to Treatment) trial. J Am Coll Cardiol. 2011 Sep 27;58(14):1414-22. doi: 10.1016/j.jacc.2011.03.068. |
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| Rest-stress Nuclear Myocardial Perfusion Imaging | Procedure | Patient receives the standard of care for emergency room admitting diagnosis of low to intermediate chest pain. A rest-stress nuclear myocardial perfusion imaging test is performed per the standard of care at each institution. |
|
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| Multi-slice Computed Tomography | Procedure | Patients admitted to the emergency department with low to intermediate chest pain receive a multi-slice computed tomographic test of the heart. |
|
|
| Washington D.C. |
| District of Columbia |
| 20010 |
| United States |
| Cleveland Clinic Florida | Weston | Florida | 33331 | United States |
| Faqua Heart Center/Piedmont Hospital | Atlanta | Georgia | 30309 | United States |
| Northwestern Memorial Hospital | Chicago | Illinois | 60611 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| William Beaumont Hospital | Royal Oak | Michigan | 48073 | United States |
| William Beaumont-Troy | Troy | Michigan | 48085 | United States |
| Minneapolis Heart Institute | Minneapolis | Minnesota | 55407 | United States |
| St. Paul Heart Clinic | Saint Paul | Minnesota | 55102 | United States |
| Mt Sinai Hospitl | New York | New York | 10029 | United States |
| Metrohealth Medical Center | Cleveland | Ohio | 44109 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Texas Heart Institute | Houston | Texas | 77030 | United States |
| MultiCare Health System-Good Samaritan Hospital | Puyallup | Washington | 98371 | United States |
| Wisconsin Heart & Vascular Center | Wauwatosa | Wisconsin | 53226 | United States |
| ID | Term |
|---|---|
| D002637 | Chest Pain |
| D003324 | Coronary Artery Disease |
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
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