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ACTIVE NOT RECRUITING
NCT06681584

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

Sponsor: National Heart Centre Singapore

View on ClinicalTrials.gov

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.

Official title: Effectiveness and Cost-effectiveness of Noninvasive Fractional Flow Reserve for Physiological Assessment in Suspected Coronary Artery Disease (ECONOMY)

Key Details

Gender

All

Age Range

21 Years - 98 Years

Study Type

OBSERVATIONAL

Enrollment

340

Start Date

2021-10-01

Completion Date

2025-05-01

Last Updated

2024-11-08

Healthy Volunteers

No

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)

Locations (3)

National University Hospital

Singapore, Singapore

National Heart Centre Singapore

Singapore, Singapore

Tan Tock Seng Hospital

Singapore, Singapore