Development and Validation of a Fast, Semi-Automated Hybrid Imaging Platform to Assess Coronary Atherosclerotic Plaque Morphology, Endothelial Shear Stress and Arterial Inflammation: A Proof of Principle Study (VALID-PET-CT)

Completed

• Conditions: Stable Angina; Coronary Artery Disease

• Registration Number: NCT04205110
• Lead Sponsor: Barts & The London NHS Trust

Brief Summary

Imaging the inside of coronary arteries (intravascular imaging) offers great insight into the assessment and treatment of coronary artery disease. Over time, substances such as fat, cholesterol and calcium can build up into 'plaques' in the arteries, causing narrowings or even blockages. These plaques can also rupture, causing cardiovascular events such as heart attacks or strokes. By using ultrasound and infrared technology, intravascular imaging can help assess these plaques, however this is an invasive technique involving angiography. Plaque composition, structure and stability can be affected by inflammation and the stress that the arteries are under. The investigators have pioneered novel minimally-invasive methods for modelling arterial stress using computed tomography coronary angiography (CTCA), as well as imaging coronary arterial inflammation using a positron emission tomography (PET) scan. Before embarking upon a large-scale clinical outcome study to determine whether these novel methods can improve risk prediction, the aim is to perform a proof-of-principle study to further develop our methodology for hybrid image analysis, and to validate this technique against high-resolution intravascular imaging as a surrogate marker of histology.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-12-13
• Study First Submitted QC: 2019-12-18
• Study First Posted: 2019-12-19
• Study Start: 2020-11-01
• Primary Completion: 2023-10-10
• Study Completion: 2023-10-10
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-04
• Last Update Posted: 2025-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Faesibility of co-registration of CTCA and PET-CT data	12 months	All studied vessels will be dividen into 3 mm segments and the CTCA and PET-CT studies will be co-registered electronically. The faesibility of this will be reported

Secondary Outcome Measures

Name	Time	Method
Comparing PET-CT, CTCA and intravascular imaging: plaque volume	12 months	The co-registered vessels will be dividen into 3 mm segments and the CTCA and PET-CT data will be compared with intravascular imaging as gold standard to compare estimations of plaque burden expressed as volume
Comparing PET-CT, CTCA and intravascular imaging: plaque composition	12 months	The co-registered vessels will be dividen into 3 mm segments and the CTCA and PET-CT data will be compared with intravascular imaging as gold standard to compare estimations of plaque composition (reported as type of plaque)
Comparing PET-CT, CTCA and intravascular imaging: haemodynamic forces	12 months	The co-registered vessels will be divided into 3 mm segments and the CTCA and PET-CT data will be compared with intravascular imaging as gold standard to compare estimations of haemodynamic forces including plaque and endothelial shear stress
Comparing PET-CT, CTCA and intravascular imaging: presence of inflammation	12 months	The co-registered vessels will be divided into 3 mm segments and the CTCA and PET-CT data will be compared with intravascular imaging as gold standard to compare assessment of markers of inflammation and vulnerability in the plaques identified

Trial Locations

Locations (1)

St Bartholomew's Hospital; 🇬🇧 London, United Kingdom