Clinical trial NCT04205110: 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)
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stable Angina
Coronary Artery Disease
Keywords: Intravascular Ultrasound
Near Infrared Spectroscopy
Positron Emission Tomography
Lead sponsor: Barts & The London NHS Trust
Sponsor class: OTHER
First posted: 2019-12-19
Enrollment: 7
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


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

Primary outcomes:
measure: Faesibility of co-registration of CTCA and PET-CT data
timeFrame: 12 months
Secondary outcomes:
measure: Comparing PET-CT, CTCA and intravascular imaging: plaque volume
timeFrame: 12 months
measure: Comparing PET-CT, CTCA and intravascular imaging: plaque composition
timeFrame: 12 months
measure: Comparing PET-CT, CTCA and intravascular imaging: haemodynamic forces
timeFrame: 12 months
measure: Comparing PET-CT, CTCA and intravascular imaging: presence of inflammation
timeFrame: 12 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: St Bartholomew's Hospital
Study officials:
References: