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)

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Stable Angina, Coronary Artery Disease

Intervention / Treatment
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* Diagnostic Test: PET-CT


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: PET-CT|PET-CT compared to intravascular imaging for assessment of atherosclerotic plaques in stable angina patients|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intravascular Ultrasound, Near Infrared Spectroscopy, Positron Emission Tomography