Coronary Artery Disease Clinical Trial
Official title:
Implementing Myocardial Computed Tomographic Perfusion in a Community Hospital Setting
The objective of this study is to carefully monitor all patients undergoing Computed Tomographic Perfusion (CTP) at Lancaster General Hospital for safety, and determine the efficiency of the CTP procedure in a community setting.
This will be a prospective, observational study designed to include a convenience sample of
all qualifying patients undergoing myocardial CTP.
The study will enroll patients who have undergone a clinically indicated CCTA for suspicion
of coronary artery disease and have a suspected coronary stenosis ≥50%-69% on that
examination. CCTA is a clinically indicated and standard of care procedure at Lancaster
General Hospital. This pilot study will enroll a convenience sample of fifteen (15) patients
at Lancaster General Hospital who satisfy all study criteria.
When a patient has a coronary CTA, physician co-investigators, all of whom are certified by
the Certification Board of Cardiovascular Computed Tomography and credentialed by Johns
Hopkins for CTP, will evaluate the scan for the presence of lesions that would qualify the
patient for inclusion. Patients with lesions between 50% and 70% will be approached for
participation in the CTP study(37). Those who agree to participate will be scheduled to have
the CTP performed within thirty (30) days of the initial Coronary CTA procedure.
The CTP procedure involves infusion of a stress agent and a contrast bolus prior to image
acquisition. The CTP examination will be graded using the standard 17-segment myocardial
model recommended by the ACCF/AHA for nuclear myocardial perfusion and stress
echocardiography, in comparison to the myocardial appearance from the baseline coronary CTA.
Areas of myocardial hypo-enhancement (decreased CT signal) under hyperemic conditions
(coronary vasodilation during the regadenoson infusion) indicate possible ischemia.
If a coronary stenosis is severe enough to reduce myocardial perfusion, then studies have
shown that an invasive therapy that includes revascularization offers benefit to the patient.
Use of CTP may allow the investigators to determine, with improved accuracy, if patients have
hemodynamically significant coronary stenoses. These results will be reported to the
patients' treating physicians and may be used in treatment planning.
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