Evaluation of Accuracy of CFD-based RuiXin-FFR by Comparing With Pressure-wire-based FFR

Sponsor

Beijing Anzhen Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04731285

Collaborator

(none)

316

Enrollment

Location

17.6

Actual Duration (Months)

17.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Coronary Artery Disease (CAD) is the top killer nowadays. Pressure-wire-based Fractional Flow Reserve (FFR) is the gold standard for measuring ischemia in coronary arteries. CFD-based RuiXin-FFR, which is noninvasive, is developed recently. But its accuracy is not verified. This is a multi-center and prospective study to evaluate the sensitivity, specificity, and accuracy of CFD-based RuiXin-FFR compared with wire-based FFR.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease Myocardial Ischemia Myocardial Fractional Flow Reserve	Diagnostic Test: Pressure wire fractional flow reserve Diagnostic Test: CFD-based RuiXin-FFR

Detailed Description

The participants are entered with suspended CAD and angiography ischemia between 30%-90% from 6 hospitals in China. Pressure-wire-based FFR is conducted in the standard protocol by each hospital. FFR>0.8 is chosen as the threshold to indicate non-ischemia. CFD-based RuiXin-FFR is performed by Raysight Medical (Shenzhen, China). CT images are acquired in a standard protocol by each hospital. Images with poor quality are excluded in this trial. Based on these images, RuiXin-FFR reconstructs the 3D model of coronary trees and obtains RuiXin-FFR values by conducting CFD simulations in a blinded fashion. RuiXin-FFR>0.8 is chosen as the threshold to indicate non-ischemia as well. By comparing the clinical diagnosis outcome of pressure-wire-based FFR and CFD-based RuiXin-FFR, the sensitivity and specificity of the RuiXin-FFR are obtained, which is the primary end point of this trial. The secondary end point includes the measurement of accuracy, NPV, PPV and ROC of the RuiXin-FFR.

Study Design

Study Type:

Observational

Actual Enrollment :

316 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Accuracy of RuiXin-FFR by Comparing With Pressure-wire-based FFR in Detecting Hemodynamically Significant Stenosis: A Prospective Multicenter Study

Actual Study Start Date :

Mar 13, 2019

Actual Primary Completion Date :

May 14, 2020

Actual Study Completion Date :

Aug 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Pressure wire based FFR Pressure wire based FFR was reference group	Diagnostic Test: Pressure wire fractional flow reserve Pressure wire is inserted into coronary arteries. The ratio of the average distal pressure and average aorta pressure is FFR.
CT-FFR CFD-based RuiXin-FFR was test group	Diagnostic Test: CFD-based RuiXin-FFR CT-FFR was evaluated in a blinded fashion with a "Coarse-to-Fine Subpixel" algorithm for lumen contour

Arm

Intervention/Treatment

Pressure wire based FFR

Pressure wire based FFR was reference group

Diagnostic Test: Pressure wire fractional flow reserve

Pressure wire is inserted into coronary arteries. The ratio of the average distal pressure and average aorta pressure is FFR.

CT-FFR

CFD-based RuiXin-FFR was test group

Diagnostic Test: CFD-based RuiXin-FFR

CT-FFR was evaluated in a blinded fashion with a "Coarse-to-Fine Subpixel" algorithm for lumen contour

Outcome Measures

Primary Outcome Measures

Sensitivity and Specificity [9 days]
By comparing with pressure-wire-based FFR, the sensitivity and specificity of CFD-based RuiXin-FFR are measured

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

able to understand the purpose of the study and sign the informed consent
with diagnosed or confirmed coronary artery disease according to the comprehensive clinical assessment
with CTA image indicating that the diameter of the reference vessel in the stenosis segment was ≥2mm
with CTA image indicating that the stenosis degree of coronary artery lumen diameter ≥30% and ≤90%

Exclusion Criteria:

prior coronary artery bypass bypass (CABG) surgery, coronary interventional therapy (PCI), artificial heart valve implantation, cardiac pacemaker or implantable defibrillator implantation
persistent or active symptoms of clinical instability, including acute chest pain (sudden onset), cardiogenic shock, unstable blood pressure status (systolic pressure less than 90 mmHg), severe congestive heart failure (NYHA grade III or IV), or acute pulmonary edema
acute myocardial infarction occurred within 7 days before inclusion
complex congenital heart disease, sick sinus syndrome, long QT syndrome, severe arrhythmia, tachycardia, severe asthma, severe or very severe chronic obstructive pulmonary disease (COPD) and chronic renal damage (serum creatinine value > 1.5 mg/dl or creatinine clearance < 45 ml/Kg*1.73 m2)
there are contraindications for the use of adenosine disodium triphosphate
allergic to iodized contrast media
pregnancy or pregnancy status unknown
life expectancy less than 2 months
there are any factors that other researchers consider not suitable for inclusion or completion of this study
obvious mismatch of coronary artery CTA images
CTA image showing calcification occupies the cross-sectional area of the lumen > 80%
CT value standard deviation of aortic root image >30HU
coronary artery occlusion.