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Clinical Trials/NCT04205110
NCT04205110
Completed
Not Applicable

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)

Barts & The London NHS Trust1 site in 1 country7 target enrollmentNovember 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stable Angina
Sponsor
Barts & The London NHS Trust
Enrollment
7
Locations
1
Primary Endpoint
Faesibility of co-registration of CTCA and PET-CT data
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 1, 2020
End Date
October 10, 2023
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Faesibility of co-registration of CTCA and PET-CT data

Time Frame: 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 Outcomes

  • Comparing PET-CT, CTCA and intravascular imaging: plaque volume(12 months)
  • Comparing PET-CT, CTCA and intravascular imaging: plaque composition(12 months)
  • Comparing PET-CT, CTCA and intravascular imaging: haemodynamic forces(12 months)
  • Comparing PET-CT, CTCA and intravascular imaging: presence of inflammation(12 months)

Study Sites (1)

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