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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
200
Patients will be randomized and prescribed either no treatment or aspirin 75mg and Atorvastatin 40mg
University Hospitals of Leicester
Leicester, United Kingdom
RECRUITINGRoyal Brompton Hospitals Trust
London, United Kingdom
RECRUITINGJohn Radcliffe Hospital
Oxford, United Kingdom
RECRUITINGEvaluate ability of new coronary CT angiogram (CCTA) scan biomarker- Fat Attenuation Index (FAI).
The overall objective is to evaluate the ability of a new cardiac CCTA scan technique, fat attenuation index (FAI), to detect changes in coronary artery perivascular fat inflammation following 8 months treatment with atorvastatin and aspirin medication
Time frame: 3year study- Two years recruitment with 8 month patient follow up
Evaluate the association between changes in Fat Attenuation Index (FAI) and plasma lipid parameters.
Evaluate this association by measuring the % of change in plasma LDL-c.
Time frame: 3year study- Two years recruitment with 8 month patient follow up
Evaluate the association between changes in Fat Attenuation Index (FAI) and plasma lipid parameters.
Evaluate this association by measuring the % of change in plasma HDL-c.
Time frame: 3year study- Two years recruitment with 8 month patient follow up
Evaluate the association between changes in Fat Attenuation Index (FAI) and plasma lipid parameters.
Evaluate this association by measuring the % of change in triglycerides.
Time frame: 3year study- Two years recruitment with 8 month patient follow up
Evaluate the association between changes in FAI and plasma biomarkers of inflammation.
Evaluate this association by measuring the % of change in plasma IL-6.
Time frame: 3year study- Two years recruitment with 8 month patient follow up
Evaluate the association between changes in FAI and plasma biomarkers of inflammation.
Evaluate this association by measuring the % of change in plasma high sensitivity C-reactive protein (hsCRP) .
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Time frame: 3year study- Two years recruitment with 8 month patient follow up