Correlation of FFR CT With Invasive FFR in Multi-ethnic Cohort- a Retrospective Study

NCT06790836 | Not Yet Recruiting

• 1 other identifier: IRAS #339186
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Coronary Artery Disease

Keywords

FFR CT; Invasive FFR; Comparison

Outcome Measures

Primary Outcomes (1)

• Correlation between FFR CT and invasive FFR.

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

  6 months

Secondary Outcomes (1)

• Assess the downstream testing after FFR CT

  6 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The existing CTCA database for patients treated at Sandwell and West Birmingham 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.

You may qualify if:

• ≥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.

You may not qualify if:

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

Sponsors & Collaborators

• Sandwell & West Birmingham Hospitals NHS Trust: lead
• Aston University: collaborator

Study Sites (1)

Sandwell and West Birmingham NHS Trust

Birmingham, West Midlands, B71 4HJ, United Kingdom

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Central Study Contacts

Vinoda Sharma, FRCP FESC FRCPE

CONTACT

0044 1215075841; vinodasharma@nhs.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Investigator

Study Record Dates

• First Submitted: January 18, 2025
• First Posted: January 24, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: January 24, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)