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)

NCT ID: NCT04205110

Last Updated: 2025-02-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 7 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-11-01
• Study Completion Date: 2023-10-10

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

PET-CT

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

1. Age ≥40

2. 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

3. Patient that is willing and can provide written informed consent.

Exclusion Criteria

1. Acute coronary syndrome within <3 months

2. Pregnancy

3. Estimated glomerular filtration rate (eGFR) <60ml/min/1.73m²

4. Previous bypass surgery

5. Decompensated heart failure, or left ventricular ejection fraction less than 30%

6. Patient allergic to contrast or cannot receive treatment with aspirin, heparin, or thienopyridines

7. Anticipated life expectancy <2 years

8. Flow limiting coronary artery disease in the proximal segments of all the 3 epicardial coronaries

9. History of heart transplantation

10. Patient that requires surgical revascularization

11. Extensive coronary artery disease (i.e., multiple chronic total occlusions) or tortuous coronary anatomy that does not allow assessment of the

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Barts & The London NHS Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

St Bartholomew's Hospital

London, , United Kingdom

Countries

United Kingdom

Other Identifiers

19/LO/1086

Identifier Type: -

Identifier Source: org_study_id