Diagnostic Performance of Fractional Flow Reserve Derived From Coronary CT Angiography

Coronary Artery Disease Clinical Trial

— ACCURATE-CT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04426396
• Other study ID #: 2019-375
• Status: Completed
• Start date: April 15, 2020
• Est. completion date: May 31, 2022

Study information

• Verified date: May 2022
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 339
• Est. completion date: May 31, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 ß - 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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Diagnostic Test:
• FFR
FFR measured by pressure wire, CT-FFR computed by coronary CT angiography

Locations

Country	Name	City	State
China	The Second Affiliated Hospital, Zhejiang University School of Medicine	Hangzhou	Zhejiang

Sponsors (2)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University	Zhejiang Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity and specificity of CT-FFR compared to FFR		1 day
Secondary	Diagnostic accuracy and AUC of CT-FFR compared to FFR		1 day