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The Evaluation of the Roles of New Cardiac Imaging in Patients With Chest Pain

NCT03800862 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 14

Last updated 2022-12-27

No results posted yet for this study

Summary

This is a prospective, observational study designed to evaluate the role of dynamic computed tomographic perfusion (CTP) and Computed Tomography-Derived Fractional Flow Reserve (CT-FFR) in patients presenting with chest discomfort.Patients with lesions greater than 50% and who meet all other inclusion/exclusion criteria will qualify to be a subject in the CTP study /CT-FFR 49. Those who agree to participate will be scheduled to have the CT-FFR and CTP performed within sixty days of the initial Coronary CTA procedure. A CTA will be performed at rest for FFR. The patient will then take approximately a 30 min break. Regadenoson will then be administered and the dynamic CT procedure will be done for perfusion. If patients are deemed to be appropriate for invasive angiography by the referring physician, coronary lesions between 40% and 80% will get a fractional flow measurement performed if indicated on a clinical basis. Stenosis in vessels less than 1.5 mm will be excluded from the study. The CT-FFR and CTP will be performed in these patients within 60 days of index coronary angiography.

Conditions

  • Cardiology
  • Radiology
  • Stenoses

Interventions

DEVICE

CT-FFR and CTP

Those who agree to participate will be scheduled to have the CT-FFR and CTP performed within sixty days of the initial Coronary CTA procedure. A CTA will be performed at rest for FFR. The patient will then take approximately a 30 min break. Regadenoson will then be administered and the dynamic CT procedure will be done for perfusion.

Sponsors & Collaborators

  • Lancaster General Hospital

    lead OTHER

Principal Investigators

  • Ron M Jacob, MD · Penn Medicine/Lancaster General Health

Eligibility

Min Age
45 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-27
Primary Completion
2022-10-27
Completion
2022-10-27
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03800862 on ClinicalTrials.gov