跳至主要内容
临床试验/NCT06790836
NCT06790836招募中不适用

Correlation of Fractional Flow Reserve Computed Tomography (FFR CT) Findings With Invasive FFR in Coronary Artery Disease (CAD) in a Multi-ethnic Cohort- a Retrospective Study

Sandwell & West Birmingham Hospitals NHS Trust2 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2026年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
500
试验地点
2
主要终点
Correlation between FFR CT and invasive FFR.

研究概览

简要总结

This study aims to examine the correlation between Fractional Flow Reserve (FFR) FFR Computed Tomography (CT) and invasive FFR in a real-world setting using retrospective analysis of existing data, providing practical insights directly applicable to patient care. By confirming or examining the accuracy of FFR CT in a clinical setting, our analysis could support its broader adoption as a routine non-invasive diagnostic tool potentially (a) reducing the need for invasive testing (b) minimising associated risks, and(c) lowering healthcare costs and provide fresh insights into non-invasive coronary diagnostics. Our findings will also help understand the relevance of these tests across different ethnic groups and the population we serve.

详细描述

This retrospective study will analyse the existing Computed Tomography Coronary Angiogram (CTCA) database for patients treated at Sandwell and West Birmingham (SWBH) National Health Service (NHS) Trust between January 1, 2019, and December 31, 2023, with the clinical team screening the database to identify patients who fit with the eligibility criteria.

The proposed study is a retrospective analysis of the clinical and imaging data over a five-year period in patients with stable chest pain (approximately 500 patients), who underwent CTCA, FFR CT, and invasive FFR at SWBH NHS Trust. The study will assess the correlation between these diagnostic measures. The aim of this investigation is to address the ongoing discrepancies in the diagnostic accuracy of FFR CT compared to the gold standard invasive FFR, which persist despite the increasing adoption of FFR CT in clinical practice. While initial trials indicated promising sensitivity and specificity for FFR CT, recent observational studies including one involving 2,298 patients who underwent FFR CT, reported varying positive and negative predictive values, with a low positive predictive value of 49% (24). This variability raised concerns about the reliability of FFR CT across different patient populations, and the real-world accuracy and cost-effectiveness of FFR CT remain subjects of ongoing debate.

This study aims to examine the correlation between FFR CT and invasive FFR in a real-world setting using existing data, providing practical insights directly applicable to patient care. By confirming or examining the accuracy of FFR CT in a clinical setting, our analysis could support its broader adoption as a routine non-invasive diagnostic tool potentially (a) reducing the need for invasive testing (b) minimising associated risks, and(c) lowering healthcare costs and provide fresh insights into non-invasive coronary diagnostics. Our findings will also help understand the relevance of these tests across different ethnic groups and the population the investigators serve.

The patient data will be identified by accessing the CTCA database, and the study will adhere to the STrengthening the Reporting of OBservational studies in Epidemiology (STROBE) guidelines (25).

The eligibility criteria are as follows:

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • •≥18 years
  • Stable •patients with suspected CAD
  • Patients who underwent CTCA, FFR CT and had an invasive FFR.
  • CTCA images of high-quality for analysis, with clear visualisation of coronary arteries and minimal artifacts.

排除标准

  • •<18 years of age
  • Did not undergo FFR CT
  • Inadequate quality/degraded CTCA images

结局指标

主要结局

Correlation between FFR CT and invasive FFR.

时间窗: 6 months

Correlation as mesured by positive predicitve value, negative predictive value, sensitivity and specificity

次要结局

  • Assess the downstream testing after FFR CT(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Vinoda Sharma

Chief Investigator

Sandwell & West Birmingham Hospitals NHS Trust

研究点 (2)

Loading locations...

相似试验

Correlation of FFR CT With Invasive FFR in... | 临床试验