Peri-vascular Adipose Tissue Inflammation Evaluated Using Coronary CT Angiography

NCT04181749 | Unknown Phase 2 DMC

• 1 other identifier: 0719
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Cardiovascular Risk Factor

Outcome Measures

Primary Outcomes (1)

• Evaluate 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

  3year study- Two years recruitment with 8 month patient follow up

Secondary Outcomes (5)

• Evaluate the association between changes in Fat Attenuation Index (FAI) and plasma lipid parameters.

  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.

  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.

  3year study- Two years recruitment with 8 month patient follow up

• Evaluate the association between changes in FAI and plasma biomarkers of inflammation.

  3year study- Two years recruitment with 8 month patient follow up

• Evaluate the association between changes in FAI and plasma biomarkers of inflammation.

  3year study- Two years recruitment with 8 month patient follow up

Study Arms (2)

No treatment

NO INTERVENTION

Patients will not be prescribed aspirin and statin

Aspirin and Atorvastatin

ACTIVE COMPARATOR

Patients prescribed aspirin and atorvastatin

Drug: aspirin and atorvastatin

Interventions

aspirin and atorvastatin DRUG

Patients will be randomized and prescribed either no treatment or aspirin 75mg and Atorvastatin 40mg

Aspirin and Atorvastatin

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must satisfy the following conditions:
• Male or Female, aged 30 to 80 years,
• CCTA scan showing mild coronary artery plaques (\<50% luminal stenosis) with a high FAI value (\>70.1 HU) within last 3 months.
• No definite clinical indication for statin treatment (i.e. do not have either cholesterol \>6.5 mM, or cholesterol \>5.0 mM and QRISK score \>10%).
• Clinical equipoise for statin and aspirin treatment, as determined by the local treating physician. In these patients, there is clinical equipoise because routine treatment with aspirin and statin is not mandated by current guidelines, but the presence of minor coronary artery plaques is frequently interpreted by clinicians as an indication for aspirin and statin treatment. Accordingly, some patients in this group typically receive aspirin and statin treatment, whereas others do not.
• Willing and able (in the Investigators opinion) to comply with all study requirements.
• Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of any incidental findings.
• Able to understand both verbal or written English

You may not qualify if:

• The participant may not enter the study if ANY of the following are known to apply:
• Previous documented history of coronary artery disease requiring treatment. This includes any of the following:
• Acute myocardial infarction Unstable angina Coronary revascularization procedure Clinically significant coronary artery disease diagnosed by invasive or non-invasive testing.
• Known diabetes mellitus
• Definite clinical indication for statin treatment (i.e. has either cholesterol \>6.5 mM, or cholesterol \>5.0 mM and QRISK score \>10%).
• Treatment with aspirin, statin or any prescribed lipid modification therapy in 6 weeks before baseline CCTA
• Atrial fibrillation (paroxysmal or persistent)
• History of New York Heart Association (NYHA) Class III or IV heart failure within the past 12 months of consent.
• Autoimmune disease requiring immunosuppressive therapy or systemic corticosteroid therapy
• Active treatment with any anti-inflammatory agents (e.g. NSAIDs, corticosteroids)
• Active neoplasm requiring surgery, chemotherapy, or radiation within the prior 12 months (subjects with a history of malignancy who have undergone curative resection or otherwise not requiring treatment for at least 12 months prior to screening with no detectable recurrence are allowed)
• Contraindication for aspirin and/or statin therapy
• Severe Chronic kidney disease (estimated glomerular filtration rate \< 30 mL/min/1.73 m² and/or serum creatinine \> 2.5 mg/dL or 220 µmol/l).
• Hepatic dysfunction (aspartate aminotransferase \[AST\] or alanine aminotransferase \[ALT\] \> 3 × the upper limit of normal \[ULN\] measured on local labs in last 6 months)
• Any clinically significant abnormality identified at the time of screening that, in the opinion of the Investigator, would preclude safe completion of the study.

Sponsors & Collaborators

• University of Leicester: lead
• University of Oxford: collaborator
• British Heart Foundation: collaborator
• National Institute for Health Research, United Kingdom: collaborator

Study Sites (3)

University Hospitals of Leicester

Leicester, LE3 9QP, United Kingdom

RECRUITING

Royal Brompton Hospitals Trust

London, SW3 6NP, United Kingdom

RECRUITING

John Radcliffe Hospital

Oxford, OX3 9DU, United Kingdom

RECRUITING

MeSH Terms

Interventions

Aspirin; Atorvastatin

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• David Adlam, Dr.

  University Hospitals of Leicester and University of Leicester

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexander

CONTACT

0116 2583839; donna.alexander@uhl-tr.nhs.uk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients randomized to No treatment or Aspirin and Statin

Study Record Dates

• First Submitted: November 19, 2019
• First Posted: November 29, 2019
• Study Start: November 18, 2020
• Primary Completion: January 31, 2024
• Study Completion: January 31, 2024
• Last Updated: December 19, 2023

Record last verified: 2023-12

Locations

GB (3)