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)

Sponsor

Barts & The London NHS Trust (Other)

Overall Status

Unknown status

CT.gov ID

NCT04205110

Collaborator

(none)

Enrollment

5.9

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stable Angina Coronary Artery Disease	Diagnostic Test: PET-CT

Study Design

Study Type:

Observational

Anticipated Enrollment :

7 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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)

Anticipated Study Start Date :

Jan 1, 2020

Anticipated Primary Completion Date :

Jun 30, 2020

Anticipated Study Completion Date :

Jun 30, 2020

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria

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.

Exclusion Criteria

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