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

NCT04731285 | Completed DMC

• 1 other identifier: 201901RX
• Study Type: observational
• Target: 316
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease; Myocardial Ischemia; Myocardial Fractional Flow Reserve

Keywords

Coronary Artery Disease; Myocardial Ischemia; FFR; FFRCT

Outcome Measures

Primary Outcomes (1)

• Sensitivity and Specificity

  By comparing with pressure-wire-based FFR, the sensitivity and specificity of CFD-based RuiXin-FFR are measured

  9 days

Study Arms (2)

Pressure wire based FFR

Pressure wire based FFR was reference group

Diagnostic Test: Pressure wire fractional flow reserve

CT-FFR

CFD-based RuiXin-FFR was test group

Diagnostic Test: CFD-based RuiXin-FFR

Interventions

Pressure wire fractional flow reserve DIAGNOSTIC_TEST

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

Pressure wire based FFR

CFD-based RuiXin-FFR DIAGNOSTIC_TEST

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

CT-FFR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population comprised 330 stable patients with suspected or known CAD who underwent CCTA, and were referred to ICA, and FFR

You may qualify if:

• 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%

You may not qualify if:

• 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
• 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
• 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.

Sponsors & Collaborators

• Beijing Anzhen Hospital: lead

Study Sites (1)

Shaoping Nie

Beijing, China

Location

Related Publications (1)

• Zeng Y, Wang X, Tang Z, Li T, Jiang X, Ji F, Zhou Y, Ge J, Li Z, Zhao Y, Ma C, Mintz GS, Nie S. Diagnostic accuracy of CT-FFR with a new coarse-to-fine subpixel algorithm in detecting lesion-specific ischemia: a prospective multicenter study. Rev Esp Cardiol (Engl Ed). 2024 Feb;77(2):129-137. doi: 10.1016/j.rec.2023.05.008. Epub 2023 Jul 13. English, Spanish.

  PMID: 37453536 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Myocardial Ischemia

Condition Hierarchy (Ancestors)

Coronary Disease; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Zhanquan Li, MD

  Liaoning Provincial People's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 7, 2020
• First Posted: January 29, 2021
• Study Start: March 13, 2019
• Primary Completion: May 14, 2020
• Study Completion: August 31, 2020
• Last Updated: September 5, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)