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Comparison of the Diagnostic Performance and Costs of FFRB Vs. Standard Care in Suspected Coronary Artery Disease.

NCT06681584 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 340

Last updated 2024-11-08

No results posted yet for this study

Summary

Chest pain due to coronary artery disease (CAD) is a main driver of healthcare costs. Fractional flow reserve (FFR) measurement during invasive coronary angiography (ICA) is the gold standard to discriminate ischemia. A rapid simplified method had been developed to determine non-invasive FFR (FFRB) by applying computational fluid dynamics (CFD) simulation on anatomic models derived from computed tomographic coronary angiography (CTCA).In this current study, the aims is to compare the diagnostic accuracy, clinical effectiveness, safety outcomes, and quality of life of using FFRB on top of CTCA for CAD diagnosis and treatment planning, versus standard of care in Singapore; and measure health care resource utilization and assess cost-effectiveness of adopting FFRB on top of CTCA to support decision making in managing patients with suspected CAD.

Conditions

Interventions

DIAGNOSTIC_TEST

CTCA

CTCA is a non-invasive test for diagnosis of anatomic coronary stenosis. Additionally, the diagnostic performance of FFRB (derived from in house calculation) with CCTA data in patients with intermediate coronary artery disease (CAD), as compared to an invasive FFR reference standard (FFR\<=0.80)

Sponsors & Collaborators

  • National Heart Centre Singapore

    lead OTHER

Principal Investigators

Eligibility

Min Age
21 Years
Max Age
98 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-01
Primary Completion
2024-05-31
Completion
2025-05-01

Countries

  • Singapore

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 NCT06681584 on ClinicalTrials.gov