The Evaluation of the Roles of New Cardiac Imaging in Patients With Chest Pain
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|ClinicalTrials.gov Identifier: NCT03800862|
Recruitment Status : Enrolling by invitation
First Posted : January 11, 2019
Last Update Posted : August 31, 2021
|Condition or disease||Intervention/treatment|
|Cardiology Radiology Stenoses||Device: CT-FFR and CTP|
|Study Type :||Observational|
|Estimated Enrollment :||50 participants|
|Official Title:||The Role of Computed Tomography-Derived Fractional Flow Reserve (CT-FFR) and Myocardial Computed Tomographic Perfusion (CTP) in Patients Presenting With Chest Discomfort|
|Actual Study Start Date :||March 27, 2019|
|Estimated Primary Completion Date :||July 3, 2027|
|Estimated Study Completion Date :||January 1, 2028|
CTP and CT-FFR
This will be a prospective, observational study designed to include a convenience sample of all qualifying patients undergoing myocardial CTP and CT-FFR.
The study will enroll patients who have chest discomfort and will require further evaluation for the presence of coronary artery disease. Patients in the study will include those who have had a clinically indicated CCTA for suspicion of coronary artery disease and are determined to have a coronary stenosis ≥50% and ≤99%. However, patients with Left main disease greater than 50% and occluded vessels Coronary Artery Disease Reporting and Data System (CAD RADS 5) will be excluded from the study. CCTA is a clinically indicated and standard of care procedure at Lancaster General Hospital.
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.
- Performance of dynamic CTP and CT-FFR for each vessel assessed in patients presenting with chest pain. [ Time Frame: Day of imaging (processing of CT-FFR images and reading of CTP images expected to be performed within 48 hours of imaging) ]Performance of CT-FFR compared to CTP for each vessel assessed, as per the below common suite of measures: sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), accuracy, discrimination
- Cardiac Long Term Outcomes [ Time Frame: MACE: One year from imaging; Performance compared to invasive FFR: Day of imaging for CT-FFR and CTP, invasive FFR performed within 60 days of imaging; Agreement in imaging subsets: Day of imaging ]One-year incidence of MACE events for subjects that undergo CTP and CT-FFR.
- Compare measures of CTP and CT-FFR with Coronary Angiography and invasive FFR (in cases where clinically indicated) [ Time Frame: MACE: One year from imaging; Performance compared to invasive FFR: Day of imaging for CT-FFR and CTP, invasive FFR performed within 60 days of imaging; Agreement in imaging subsets: Day of imaging ]Sensitivity, specificity, PPV, NPV, accuracy, and discrimination of CTP and CT-FFR compared to invasive FFR. Invasive FFR results may be obtained during Coronary Angiography in cases where clinically indicated. If FFR is not performed by invasive angiography a reference standard of >50% stenosis by invasive coronary angiography will be taken when conventional stress testing has demonstrated ischemia in the distribution supplied by the vessel with stenosis.
- Outcome agreement CTP and CT-FFR (when CT-FFR values are <.80 and >0.80 [ Time Frame: MACE: One year from imaging; Performance compared to invasive FFR: Day of imaging for CT-FFR and CTP, invasive FFR performed within 60 days of imaging; Agreement in imaging subsets: Day of imaging ]Agreement between CTP and CT-FFR when CT-FFR values are < .80 and >0.80.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03800862
|United States, Pennsylvania|
|Penn Medicine / Lancaster General Hospital|
|Lancaster, Pennsylvania, United States, 17602|
|Principal Investigator:||Ron M Jacob, MD||Penn Medicine/Lancaster General Health|