Cardiovascular Inflammation Reduction Trial - Inflammation Imaging Study

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.

Conditions

• Vascular Inflammation
• Atherosclerotic Cardiovascular Disease

Interventions

DRUG

Low dose methotrexate

Study participants will additionally receive 1 mg daily oral folate.

DRUG

Placebo

Sponsors & Collaborators

• Brigham and Women's Hospital

  collaborator OTHER

• Massachusetts General Hospital

  collaborator OTHER

• Unity Health Toronto

  collaborator OTHER

• National Institutes of Health (NIH)

  collaborator NIH

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• Icahn School of Medicine at Mount Sinai

  lead OTHER

Principal Investigators

• Zahi Fayad, PhD · Icahn School of Medicine at Mount Sinai

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2015-12-18

Primary Completion

2019-03-29

Completion

2019-03-29

Countries

• United States
• Canada

Study Locations