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Evaluation of Health Economics for Noninvasive Coronary Fractional Flow Reserve Measurement Technology

NCT05593120 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 600

Last updated 2022-10-25

No results posted yet for this study

Summary

To determine whether, in a Chinese population of patients presenting to Wuhan Asia Heart Hospital, Fractional Flow Reserve Derived from Coronary Computed Tomography Angiography (CT-FFR) as a default test is noninferior in terms of total costs when compared to routine clinical pathway recommended by the investigator and the institution's heart team.

Conditions

Interventions

DIAGNOSTIC_TEST

CT-FFR

In the test group all patients who are eligible for CTA will undergo CTA as their default test. Those patients with any coronary stenosis 30%-90% data in at least one major epicardial vessel will be referred for CT-FFR. In patients in whom CT-FFR analysis is performed, FFR will be derived for all vessels. CT-FFR will be evaluated in a blinded fashion with a "Coarse-to-Fine Subpixel" algorithm for lumen contour. The data derived from this test will determine their management strategy.

DIAGNOSTIC_TEST

Routine care

All patients in the routine care group will be assessed according to their current conventional pathways that are based upon routine practice in Wuhan Asia Heart Hospital. The trial will encourage the routine and standard assessment and management of all patients (anticipated outcomes include ETT, stress echo, stress MR, nuclear perfusion, CTA, CT calcium, invasive CA, reassurance).

Sponsors & Collaborators

  • Wuhan Asia Heart Hospital

    collaborator OTHER

  • Shenzhen Raysight Intelligent Medical Technology Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Xiaojing Ma · Wuhan Asia Heart Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-29
Primary Completion
2022-11-30
Completion
2022-12-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05593120 on ClinicalTrials.gov