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) (VALID-PET-CT)

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.

Study Overview

• Status: Unknown
• Conditions: Coronary Artery Disease; Stable Angina
• Intervention / Treatment: Diagnostic test: PET-CT

• Study Type: Observational
• Enrollment (Anticipated): 7

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparing PET-CT, CTCA and intravascular imaging: plaque volume	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	12 months
Comparing PET-CT, CTCA and intravascular imaging: plaque composition	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)	12 months
Comparing PET-CT, CTCA and intravascular imaging: haemodynamic forces	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	12 months
Comparing PET-CT, CTCA and intravascular imaging: presence of inflammation	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	12 months

Collaborators and Investigators

• Sponsor: Barts & The London NHS Trust

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2020
• Primary Completion (Anticipated): June 30, 2020
• Study Completion (Anticipated): June 30, 2020

Study Registration Dates

• First Submitted: December 13, 2019
• First Submitted That Met QC Criteria: December 18, 2019
• First Posted (Actual): December 19, 2019

Study Record Updates

• Last Update Posted (Actual): December 23, 2019
• Last Update Submitted That Met QC Criteria: December 19, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: Positron Emission Tomography; Near Infrared Spectroscopy; Intravascular Ultrasound
• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Pain; Neurologic Manifestations; Pathological Conditions, Anatomical; Vasculitis; Coronary Disease; Chest Pain; Angina Pectoris; Coronary Artery Disease; Inflammation; Angina, Stable; Arteritis; Plaque, Atherosclerotic
• Other Study ID Numbers: 19/LO/1086

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No