NCT02756234

Implementing Myocardial Computed Tomographic Perfusion in a Community Hospital Setting

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 19 (actual)
• Sponsor: Lancaster General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Coronary Artery Disease

Timeline

• Start date: 2016-05-01
• Primary completion: 2018-08-30
• Completion: 2018-08-30
• First posted: 2016-04-29
• Last updated: 2018-12-06

Locations

1 site across 1 country: United States