Chest Pain Clinical Trial
Official title:
Coronary Computed Tomography for Systematic Triage of Acute Chest Pain Patients to Treatment (CT-STAT)
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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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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