Evaluating inflammation in coronary arteries using CT imaging

Peri-vascular Adipose Tissue Inflammation Evaluated Using Coronary CT

This study is testing if a new way of using CT scans can help spot inflammation in the coronary arteries of patients taking standard heart medications.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 30 Years to 80 Years
• Sex: All
• Sponsor: University of Leicester (Academic / other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 3 sites (Leicester and 2 other locations)
• Trial ID: NCT04181749 on ClinicalTrials.gov

What this trial studies

The P-VECT Study aims to assess the effectiveness of coronary CT angiography (CCTA)-derived Fat Attenuation Index (FAI) measurements in detecting changes in coronary artery inflammation in patients receiving standard treatment with atorvastatin and aspirin. This pilot study will involve patients with mild coronary artery plaques and high FAI values, who will undergo a series of visits for blood tests and medication supply. The findings will help establish the rationale for future pivotal trials to evaluate the clinical effectiveness of FAI in managing cardiovascular risks.

Who should consider this trial

Good fit: Ideal candidates are males and females aged 30 to 80 with mild coronary artery plaques and high FAI values who are not currently indicated for statin treatment.

Not a fit: Patients with significant coronary artery disease or those already on statin treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved methods for detecting and managing coronary artery inflammation, potentially reducing cardiovascular risks for patients.

How similar studies have performed: Other studies have shown promise in using imaging techniques to assess coronary artery inflammation, but this specific approach with FAI is novel.

Eligibility criteria

Inclusion Criteria:

Participants must satisfy the following conditions:

1. Male or Female, aged 30 to 80 years,
2. CCTA scan showing mild coronary artery plaques (\<50% luminal stenosis) with a high FAI value (\>70.1 HU) within last 3 months.
3. 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%).
4. 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.
5. Willing and able (in the Investigators opinion) to comply with all study requirements.
6. Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of any incidental findings.
7. Able to understand both verbal or written English

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Exclusion Criteria:

* The participant may not enter the study if ANY of the following are known to apply:

  1. 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.
  2. Known diabetes mellitus
  3. Definite clinical indication for statin treatment (i.e. has either cholesterol \>6.5 mM, or cholesterol \>5.0 mM and QRISK score \>10%).
  4. Treatment with aspirin, statin or any prescribed lipid modification therapy in 6 weeks before baseline CCTA
  5. Atrial fibrillation (paroxysmal or persistent)
  6. History of New York Heart Association (NYHA) Class III or IV heart failure within the past 12 months of consent.
  7. Autoimmune disease requiring immunosuppressive therapy or systemic corticosteroid therapy
  8. Active treatment with any anti-inflammatory agents (e.g. NSAIDs, corticosteroids)
  9. 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)
  10. Contraindication for aspirin and/or statin therapy
  11. 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).
  12. Hepatic dysfunction (aspartate aminotransferase \[AST\] or alanine aminotransferase \[ALT\] \> 3 × the upper limit of normal \[ULN\] measured on local labs in last 6 months)
  13. Any clinically significant abnormality identified at the time of screening that, in the opinion of the Investigator, would preclude safe completion of the study.
  14. Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
  15. Participants who have participated in another research study involving a treatment intervention or an investigational product, in the past 12 weeks.
  16. Patients unable to understand verbal or written English.
  17. Contraindication to contract dye for CCTA.
  18. Pregnancy

Where this trial is running

Leicester and 2 other locations

• University Hospitals of Leicester — Leicester, United Kingdom (Recruiting)
• Royal Brompton Hospitals Trust — London, United Kingdom (Recruiting)
• John Radcliffe Hospital — Oxford, United Kingdom (Recruiting)

Study contacts

• Principal investigator: David Adlam, Dr. — University Hospitals of Leicester and University of Leicester
• Study coordinator: Alexander

Conditions Cardiovascular Risk Factor