Diagnostic Performance of Fractional Flow Reserve Derived From Coronary CT Angiography

Completed

• Conditions: Coronary Artery Disease

• Registration Number: NCT04426396
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-04-15
• Study First Submitted: 2020-06-07
• Study First Submitted QC: 2020-06-07
• Study First Posted: 2020-06-11
• Primary Completion: 2021-12-31
• Status Verified: 2022-05
• Study Completion: 2022-05-31
• Last Update Submitted: 2023-03-06
• Last Update Posted: 2023-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 339

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;
• CT-FFR can not be calculated because of the quality of CTA image;
• Known pregnant and lactating women;
• Having participated in other clinical trials within 3 months;
• Other situations that the researchers judged were not suitable for inclusion.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sensitivity and specificity of CT-FFR compared to FFR	1 day

Secondary Outcome Measures

Name	Time	Method
Diagnostic accuracy and AUC of CT-FFR compared to FFR	1 day

Trial Locations

Locations (1)

The Second Affiliated Hospital, Zhejiang University School of Medicine; 🇨🇳 Hangzhou, Zhejiang, China