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)

NCT04205110 | Completed DMC

• 1 other identifier: 19/LO/1086
• Study Type: observational
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Stable Angina; Coronary Artery Disease

Keywords

Intravascular Ultrasound; Near Infrared Spectroscopy; Positron Emission Tomography

Outcome Measures

Primary Outcomes (1)

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

  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

  12 months

Secondary Outcomes (4)

• 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

Interventions

PET-CT DIAGNOSTIC_TEST

PET-CT compared to intravascular imaging for assessment of atherosclerotic plaques in stable angina patients

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Stable angina patients with known coronary artery disease referred for further invasive assessment as part of routine clincal care

You may qualify if:

• Age ≥40
• Stable angina, defined as typical symptoms with evidence of reversible ischemia in non-invasive test and/or documented obstructive coronary artery disease on coronary angiography
• Patient that is willing and can provide written informed consent.

You may not qualify if:

• Acute coronary syndrome within \<3 months
• Pregnancy
• Estimated glomerular filtration rate (eGFR) \<60ml/min/1.73m²
• Previous bypass surgery
• Decompensated heart failure, or left ventricular ejection fraction less than 30%
• Patient allergic to contrast or cannot receive treatment with aspirin, heparin, or thienopyridines
• Anticipated life expectancy \<2 years
• Flow limiting coronary artery disease in the proximal segments of all the 3 epicardial coronaries
• History of heart transplantation
• Patient that requires surgical revascularization
• Extensive coronary artery disease (i.e., multiple chronic total occlusions) or tortuous coronary anatomy that does not allow assessment of the

Sponsors & Collaborators

• Barts & The London NHS Trust: lead

Study Sites (1)

St Bartholomew's Hospital

London, EC1A 7BE, United Kingdom

Location

MeSH Terms

Conditions

Angina, Stable; Coronary Artery Disease

Interventions

Positron Emission Tomography Computed Tomography

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

Positron-Emission Tomography; Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography, X-Ray Computed; Multimodal Imaging; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2019
• First Posted: December 19, 2019
• Study Start: November 1, 2020
• Primary Completion: October 10, 2023
• Study Completion: October 10, 2023
• Last Updated: February 6, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)