Diagnostic Performance of Noninvasive Fractional Flow Reserve From Computed Tomography

Phase 4

• Conditions: Coronary Artery Disease
• Interventions: Device: FFR (PressureWire)

• Registration Number: NCT01747317
• Lead Sponsor: Shanghai 10th People's Hospital

Brief Summary

Fractional Flow Reserve derived from computed tomography(FFRCT) is a novel method for determining the physiologic significance of coronary artery disease (CAD), which will help physicians in clinical decision-making and decrease the medical cost, but its ability to identify patients with ischemia has not been adequately examined to date.

Detailed Description

Fractional Flow Reserve derived from computed tomography(FFRCT) is a novel method for determining the physiologic significance of coronary artery disease (CAD), which will help physicians in clinical decision-making and decrease the medical cost, but its ability to identify patients with ischemia has not been adequately examined to date.

Available data from registered clinical trials has testified the diagnostic performance of FFRCT, but the diagnostic accuracy among them are not consistent.

Thus, the investigators designed a collaborative individual patient-data pooled-analysis aimed to assess the diagnostic accuracy of FFRCT and find the possible cause for inconsistency

Study Timeline

• Status Verified: 2012-12
• Study Start: 2012-12
• Study First Submitted: 2012-12-09
• Study First Submitted QC: 2012-12-10
• Last Update Submitted: 2012-12-10
• Study First Posted: 2012-12-11
• Last Update Posted: 2012-12-11
• Primary Completion: 2013-03
• Study Completion: 2013-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Coronary computed tomographic angiography(CCTA) with over 50 percent stenosis in a major coronary artery over 2mm diameter
• Undergoing clinically indicated invasive coronary angiography with FFR

Exclusion Criteria

• A history of CABG surgery
• Prior percutaneous coronary intervention with suspected instent restenosis
• Suspicion of or recent acute coronary syndrome
• Complex congenital heart disease
• Prior pacemaker or defibrillator
• Prosthetic heart valve
• Significant arrhythmia
• heart rate >100 beats/min
• systolic blood pressure≤90 mmHg
• contraindication to beta blockers, nitroglycerin or adenosine
• Serum creatinine level greater than 1.5 mg per dL
• Allergy to iodinated contrast
• Pregnant state
• Body mass index greater than 35
• Evidence of active clinical instability or lifethreatening disease
• Canadian Cardiovascular Society class IV angina
• nonevaluable CCTA as determined by the CCTA core laboratory
• Inability to adhere to study procedures

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single arm study	FFR (PressureWire)	Single arm study.The investigators will conduct computed tomography,angiography and FFR measurement during angiography in this single arm.

Primary Outcome Measures

Name	Time	Method
Diagnostic Accuracy of FFRCT	1 day	Diagnostic accuracy\[Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV)\]\* of FFRCT to determine presence or absence of at least one hemodynamically (HD)-significant coronary artery stenosis at the subject level using binary outcomes when compared to FFR as the reference standard..\*Sensitivity measures the proportion of actual positives which are correctly identified. Specificity measures the proportion of negatives which are correctly identified;PPV, or precision rate is the proportion of positive test results that are true positives (such as correct diagnoses);NPV is defined as the proportion of subjects with a negative test result who are correctly diagnosed.

Secondary Outcome Measures

Name	Time	Method
Diagnostic accuracy of FFRCT at the subject level	1 day	Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of FFRCT at the subject level using binary outcomes when compared to FFR as the reference standard.
Diagnostic accuracy of FFRCT at the vessel level	1 day	Sensitivity, specificity, PPV and NPV of FFRCT for the presence or absence of HD-significant coronary artery stenosis at the vessel level using binary outcomes when compared to FFR as the reference standard.
FFR Numerical Correlation	1 day	Per-vessel correlation of the FFRCT numerical value alone with the FFR numerical value measured during cardiac catheterization.

Trial Locations

Locations (1)

Department of Cardiology, Shanghai Tenth People's Hospital; 🇨🇳 Shanghai, China