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NCT02576067 · ClinicalTrials.gov registry record · Phase 3
Cardiovascular Inflammation Reduction Trial - Inflammation Imaging Study
A Phase 3 study of Atherosclerotic Cardiovascular Disease and Vascular Inflammation, sponsored by Icahn School of Medicine at Mount Sinai.
- Completed
- Registry status
- Phase 3
- Development phase
- 123
- Enrollment target
- 3
- Study locations
NCT02576067: Completed Phase 3 study of Atherosclerotic Cardiovascular Disease and Vascular Inflammation, sponsored by Icahn School of Medicine at Mount Sinai.
NCT02576067 is a Phase 3 study of Atherosclerotic Cardiovascular Disease and Vascular Inflammation that has completed, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 123 participants, below the 7,562-participant average among 21 other Atherosclerotic Cardiovascular Disease trials with a reported enrollment target (98% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02576067, a Phase 3 study of Atherosclerotic Cardiovascular Disease and Vascular Inflammation, has completed, sponsored by Icahn School of Medicine at Mount Sinai.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 123 participants
- Enrollment target
- 3
- Study locations
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.
Primary Outcome
Change in arterial inflammation - The relative change at 8 months as compared to baseline in arterial inflammation as measured by the most diseased segment (MDS) of the index vessel. The MDS is defined as the 1.5 cm segment within the carotid artery (right or left carotid) that demonstrates the highest PET/CT activity, and is calculated as a mean of maximum TBR values derived from 3 contiguous axial segments. The index vessel in turn is defined as the vessel (either aorta, right, or left carotid
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Low dose methotrexate
Study Locations (3)
Massachusetts
- Massachusetts General Hospital - Boston
New York
- Icahn School of Medicine at Mount Sinai - New York
Ontario
- St. Michael's Hospital - Toronto
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 123 participants |
| Start Date | 2015-12-18 |
| Est. Completion | 2019-03-29 |
| Phase | Phase 3 |
What the finished NCT02576067 record still lists
NCT02576067 is an interventional study that assigns participants to a tested intervention. The registered 123 participants enrollment target is mid-sized for trials with a published cap, below the 7,562-participant average among 21 other Atherosclerotic Cardiovascular Disease trials with a reported enrollment target (98% lower).
The record links to 2 conditions, with Atherosclerotic Cardiovascular Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02576067 reports a single indexed study location in Massachusetts, New York, Ontario.
Frequently Asked Questions
What is clinical trial NCT02576067 about?
NCT02576067 is a clinical study titled "Cardiovascular Inflammation Reduction Trial - Inflammation Imaging Study". 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 ass...
What is the current status of trial NCT02576067?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 123 participants. The study started on 2015-12-18. Estimated completion is 2019-03-29.
What conditions does trial NCT02576067 study?
This clinical trial studies the following conditions: Atherosclerotic Cardiovascular Disease, Vascular Inflammation.
What interventions are being tested in trial NCT02576067?
The interventions under investigation include: Placebo (DRUG), Low dose methotrexate (DRUG).
Who is sponsoring clinical trial NCT02576067?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02576067 being conducted?
This trial has 3 study locations across Massachusetts, New York, Ontario. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02576067's enrollment target sits among peer trials
123 18th of 21 higher than 4 of 21 other Atherosclerotic Cardiovascular Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Atherosclerotic Cardiovascular Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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