Coronary CT Angiography-Derived Fractional Flow Reserve for Functional Evaluation of Coronary Artery Disease

Second Affiliated Hospital, School of Medicine, Zhejiang University1 site in 1 country339 target enrollmentApril 15, 2020

ConditionsCoronary Artery Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Coronary Artery Disease
Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Enrollment: 339
Locations: 1
Primary Endpoint: Sensitivity and specificity of CT-FFR compared to FFR
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is a blind evaluation, self-control, multicenter clinical trial designed to determine the diagnostic performance of CT-FFR from coronary computed tomographic angiography (CCTA), as compared to CCTA alone, for non-invasive diagnosis of the presence of a hemodynamically significant coronary stenosis, using invasive fractional flow reserve (FFR) as the reference standard.

Registry

clinicaltrials.gov

Start Date

April 15, 2020

End Date

May 31, 2022

Last Updated

3 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age≥ 18 years old;
•Subjects with clinical need and consent for coronary angiography;
•Can provide the results of coronary CT angiography within 60 days prior to ICA or agree to undergo coronary CT angiography;
•The subjects knew about the experiment and signed the informed consent voluntarily.

Exclusion Criteria

•Patients who have had percutaneous coronary intervention (PCI);
•Patients who had CABG;
•Acute coronary syndrome, such as acute ST segment elevation;
•Severe tachycardia or arrhythmia;
•Patients with severe hepatorenal insufficiency;
•Patients with congenital heart disease, implanted pacemaker or defibrillator, artificial heart valve;
•Failure to perform invasive FFR examination or obtain FFR value due to various reasons;
•Allergic to β - blockers, nitrates and adenosine, sick sinus syndrome, long QT syndrome, severe hypotension, severe asthma, severe COPD or COPD;
•Persistent or significant clinical instability, including acute chest pain (sudden onset), cardiogenic shock, blood pressure instability (systolic blood pressure \< 90mmHg) and severe congestive heart failure (according to the heart classification of the New York Heart Association, grade III or IV of cardiac function) or acute pulmonary edema;
•The CTA images of coronary artery showed that the stenosis rate was less than 30% or greater than 90%, or the diameter of diseased segment was less than 2.0mm;