Role of On-site CT-derived FFR in the Management of Suspect CAD Patients

Summary

The primary of this registry is to evaluate whether the availability of CTA/CT-FFR procedure could effectively optimize the flow of clinical practice of stable chest pain versus conventional clinical pathway in decision making, avoid the overuse of invasive procedure, finally improve clinical prognosis and reduce total medical expenditure. This registry is randomized, open labeled, prospective designed and will be performed in 6 Chinese hospitals. Approximately 1200 subjects will be enrolled and subsequently assigned to either routine clinically-indicated diagnostic care group (CID arm) or CTA/CT-FFR care group (CTA/CT-FFR arm) via computer-generated random numbers (1:1 ratio)

Conditions

• Coronary Artery Disease

Interventions

DIAGNOSTIC_TEST

CT-FFR assessment

When subjects are randomized to the CTA/CT-FFR arm, FFR based on the coronary CTA imaging will be measured. DEEPVESSEL FFR workstation is very dedicated software utilizing the original CTA imaging to meter simulated FFR values based on a machine learning algorithm. The first step is to extract a 3D coronary artery model and generate coronary centerlines which are similar to the routine reconstruction of coronary CTA. The centerlines are extracted using a minimal path extraction filter. Then a novel path-based deep learning model, referred to DEEPVESSEL FFR, is used to predict the simulated FFR values on the vascular centerlines. Deep learning algorithm is used to establish characteristic sample database of coronary hemodynamics characteristic parameters. When deep training model is proved to be valid, it is applied to a new lesion-specific measurement. Lesion-specific CT-FFR is defined as simulated FFR value at distance of 20mm away from the lesion of interest.

Sponsors & Collaborators

• Beijing Anzhen Hospital

  collaborator OTHER

• First Affiliated Hospital of Xinjiang Medical University

  collaborator OTHER

• Qilu Hospital of Shandong University

  collaborator OTHER

• Second Affiliated Hospital, School of Medicine, Zhejiang University

  collaborator OTHER

• Tongji Hospital

  collaborator OTHER

• Chinese PLA General Hospital

  lead OTHER

Principal Investigators

• Yundai Chen, Ph.D. · Chinese PLA General Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

40 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-05-10

Primary Completion

2022-10-30

Completion

2022-10-31

Countries

• China

Study Locations