NCT04181749

Peri-vascular Adipose Tissue Inflammation Evaluated Using Coronary CT Angiography

Peri-vascular Adipose Tissue Inflammation Evaluated Using Coronary CT

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: University of Leicester · Academic / Other
• Sex: All
• Age: 30 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The P-VECT Study proposes to test the use of CCTA-derived FAI measurements in a group of patients with coronary artery inflammation, who will receive routinely-used statin and aspirin treatment. The P-VECT Study is a pilot study that will provide the rationale and data for power calculations to enable design of pivotal trials of the clinical effectiveness of FAI.

Detailed description

In this research we will study the ability of coronary CT angiography (CCTA)- derived Fat Attenuation Index (FAI) measurements to detect changes in coronary artery inflammation following treatment with atorvastatin and aspirin . CT scan images are used to evaluate the presence of atherosclerotic plaque in the wall of the coronary arteries. The new CCTA technique, FAI, detects and quantifies coronary artery inflammation by analysis of the characteristics of the adipose tissue (fat) around the wall of the artery - the peri-vascular adipose tissue (PVAT) This is a pilot study, involving patients undergoing a clinically indicated CCTA as part of their routine clinical care who are shown (on their scans) to have mild coronary artery plaques (\<50% luminal stenosis) with a high FAI value (\>70.1 HU). Patients will have 6 visits (one of which screening) with hospital attendance on 3 occasions for blood tests and drug supply. The pilot study will provide the rationale for power calculations from which further studies can be developed to evaluate the clinical effectiveness of FAI.

Conditions

• Cardiovascular Risk Factor

Interventions

Type	Name	Description
DRUG	aspirin and atorvastatin	Patients will be randomized and prescribed either no treatment or aspirin 75mg and Atorvastatin 40mg

Timeline

• Start date: 2020-11-18
• Primary completion: 2024-01-31
• Completion: 2024-01-31
• First posted: 2019-11-29
• Last updated: 2023-12-19

Locations

3 sites across 1 country: United Kingdom