Cardiovascular Inflammation Reduction Trial - Inflammation Imaging Study
Status:
Completed
Trial end date:
2019-03-29
Target enrollment:
Participant gender:
Summary
Vascular inflammation, a central feature of atherosclerosis, participates in the initiation,
perpetuation and instability of plaques. Multiple clinical trials of cholesterol lowering
therapy with statins have demonstrated that reductions in atherosclerotic cardiovascular
disease (CVD) events are associated with reductions in both LDL cholesterol (LDL-C) and the
systemic inflammatory mediator C-reactive protein (CRP). The Cardiovascular Inflammation
Reduction Trial (CIRT) investigates if an anti-inflammatory agent commonly used in rheumatoid
arthritis (low dose methotrexate (LDM)) can reduce CV morbidity and mortality among patients
with a prior myocardial infarction or angiographically demonstrated multivessel coronary
artery disease (GCO#13-1467).
In this ancillary CIRT imaging study, the investigators propose to use this well validated
approach by non-invasive serial FDG-PET/CT imaging in a subset of patients enrolled in the
main CIRT trial to directly visualize vascular inflammation. Once the subjects are enrolled
in the main CIRT trial, baseline imaging will be done and follow up imaging will be done
approximately 8 months after the baseline imaging.
18FDG-PET imaging data will be acquired, analyzed centrally and results incorporated into the
main CIRT database. The investigators hypothesize that LDM treatment will result in a
significant decrease in plaque inflammation as measured by 18-FDG-PET/CT after 8 months as
compared to placebo.
Phase:
Phase 3
Details
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Collaborators:
Brigham and Women's Hospital Massachusetts General Hospital National Heart, Lung, and Blood Institute (NHLBI) National Institutes of Health (NIH) St. Michael's Hospital, Toronto Unity Health Toronto