Coronary Disease Clinical Trial
Official title:
Multi-Detector Computer Tomography(MDCT)in Patients With Equivocal/Intermediate Post Test Probability of Coronary Artery Disease
The purpose of this study is to evaluate the usefulness of performing a "cat scan" of the
heart arteries in patients (without a known history of heart disease) seen by their
physician for chest pain. We plan to evaluate this test in patients who have already
undergone stress testing. On occasion, stress test results are equivocal or suspected to be
inaccurate. In these cases, depending on the overall clinical suspicion of coronary artery
disease, physicians may recommend cardiac catheterization to determine whether or not
patients have blockages in their heart's arteries. We plan to evaluate whether a Cat Scan of
the heart arteries will provide your physician with important information to assist in this
decision. If the results of this test are normal, the patient may not require a heart
catheterization; alternatively, if the test is abnormal, a physician may proceed with
catheterization after review of the data. There will 200 patients enrolled into the study.
All patients will be followed by their usual cardiologist, and all decisions will be made by
their cardiologist.
Computed tomography (CT; "cat scan") is an x-ray test routinely used for diagnostic
purposes. Cardiac computed tomography using the newer generation multislice CT (MSCT)
scanners is an improved way of using CT scanning techniques to look at the heart and blood
vessels of the body. The images of the coronary arteries obtained by MSCT scanners (during a
5-10 minute procedure) are highly accurate, when compared to the conventional invasive
cardiac catheterization procedure. This procedure will provide a calculation of a coronary
artery calcium score as well as an accurate depiction of the coronary anatomy. The accuracy
of this test is similar to that achieved with traditional stress test imaging, but has some
inherent advantages over this traditional stress testing. Therefore, we believe that in
patients with intermediate, inconclusive, or suspected inaccurate stress tests, MSCT of the
coronary arteries may provide helpful information to your physician to help guide their
decision regarding the need (or lack of) for possible invasive cardiac catheterization. This
procedure is considered an ideal "screening test" to exclude the presence of coronary artery
disease in patients with suspected coronary artery disease.
On the day of your procedure, the patient will be given intravenous ("IV dye") contrast
during their Cat Scan. We will also draw a blood sample to assess your kidney function
and/or pregnancy status (if necessary). The contrast is what creates the pictures of one's
arteries. The intravenous contrast used is the same dye as that used for routine cat scans
of other parts of the body, as well as for cardiac catheterization. Prior to the Scan
patients may be prescribed a medicine called a beta blocker The beta blocker typically used
is called Atenolol. This medication slows your heart rate and is one that is commonly used
to treat high blood pressure. Dosing will be based upon your current medications and vital
signs. If a patient's heart rate is greater than 60 beats per minute an intravenous
beta-blocker may be given to optimize their heart images. Patient's will have to hold your
breath twice, for up to 30 seconds each time. The imaging part of the test takes about 10
minutes. Patient's will be observed after the test for about 20 minutes, followed by
discharge home. Physicians will called with the patient's results of the study, and they
will contact their patient's regarding the results, as well as the "next step." If a patient
is a diabetic (taking metformin/glucophage), we will request a follow up (the next day)
kidney test. Patient's will also will be called at 3 months to asked a few brief questions
regarding your health (any recent hospitalizations, any new medical illnesses, any follow up
heart testing, etc.)
The purpose of this observational study is to prospectively evaluate the impact of multi
detector CT angiography (MDCT) in patients with equivocal/intermediate post exercise stress
test probability of coronary artery disease.
The primary objective are to:
1. Evaluate the diagnostic and prognostic performance of MDCT in patients with equivocal/
intermediate post test probability of CAD and
2. Evaluate the accuracy of MDCT in prediction of 30 day major adverse events.
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