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.
Study Type
OBSERVATIONAL
Enrollment
19
Lancaster General Heatlh / Penn Medicine
Lancaster, Pennsylvania, United States
Number of participants with treatment-related adverse events as a result of CTP procedure.
Safety will be monitored by medical personnel and recorded from observations, patient interviews and the medical record during the index hospital visit(s) for CTP, from the medical record, and outpatient office records.
Time frame: Through study completion, expected 1 year.
Number of days for a subject to be scheduled and complete CTP procedure post CCTA procedure.
Days from CCTA to completed CTP procedure.
Time frame: 30 days
Number of minutes it takes for CTP procedure to be completed on a subject. to complete a CTP procedure.
Time (minutes) from initiation to completion of CTP procedure.
Time frame: 90 minutes
Number of minutes for a Provider to review and interpret CTP data and report out on CTP procedure.
Time (minutes) to interpret the CTP procedure.
Time frame: 30 minutes
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