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)

Coronary Artery Disease Clinical Trial

— 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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04205110
• Other study ID #: 19/LO/1086
• Status: Not yet recruiting
• Start date: January 1, 2020
• Est. completion date: June 30, 2020

Study information

• Verified date: December 2019
• Source: Barts & The London NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 7
• Est. completion date: June 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Angina, Stable
• Arteritis
• Coronary Artery Disease
• Inflammation
• Plaque, Atherosclerotic
• Stable Angina

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Barts & The London NHS Trust

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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