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NCT04271540 · ClinicalTrials.gov registry record · Phase 4
MIcrovascular dysfuNction In Moderate-severe Psoriasis
A Phase 4 study of Cardiovascular Disease and Psoriasis, sponsored by Marcelo F. Di Carli, MD, FACC.
- Completed
- Registry status
- Phase 4
- Development phase
- 36
- Enrollment target
- 1
- Study location
NCT04271540: Completed Phase 4 study of Cardiovascular Disease and Psoriasis, sponsored by Marcelo F. Di Carli, MD, FACC.
NCT04271540 is a Phase 4 study of Cardiovascular Disease and Psoriasis that has completed, run by Marcelo F. Di Carli, MD, FACC. The registered enrollment target is 36 participants, below the 2,697-participant average among 137 other Cardiovascular Disease trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04271540, a Phase 4 study of Cardiovascular Disease and Psoriasis, has completed, sponsored by Marcelo F. Di Carli, MD, FACC.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 36 participants
- Enrollment target
- 1
- Study location
Study Summary
Psoriasis, a common chronic inflammatory skin disease affecting approximately 2% of the population, is associated with increased cardiovascular (CV) risk. Despite the implication of inflammation in this excess risk, it remains unclear whether reducing inflammation reduces the risk of cardiac events. This study proposes to test whether Tildrakizumab, an FDA approved therapy for psoriasis that blocks IL-23 and the Th17 pathway of inflammation, improves coronary vascular function and coronary flow reserve, as measured by noninvasive imaging with cardiac positron emission tomography. In so doing, improvement in coronary vasoreactivity, endothelial function, and tissue perfusion may have beneficial effects on myocardial mechanics, left ventricular deformation and function and, ultimately, symptoms and prognosis. This research may offer novel insights into the contributors of CV risk in psoriasis and provide data to support the development of strategies to prevent cardiovascular events in psoriatic disease.
Primary Outcome
Change (from baseline) in global CFR, as measured by PET imaging at 24 weeks after initiation of Tildrakizumab therapy. Coronary flow reserve (CFR), the ratio of peak vasodilator stress to rest myocardial blood flow (MBF), represents the maximal ability to augment coronary flow and myocardial perfusion. Absolute MBF was computed from the rest and stress myocardial perfusion PET images using commercially available software (Corridor4DM; Ann Arbor, Michigan) and a two-compartment tracer kinetic m
Conditions Studied
Interventions
- DRUG Tildrakizumab
Study Locations (1)
Massachusetts
- Brigham and Women's Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2020-04-04 |
| Est. Completion | 2024-07-17 |
| Phase | Phase 4 |
What the finished NCT04271540 record still lists
NCT04271540 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 2,697-participant average among 137 other Cardiovascular Disease trials with a reported enrollment target (99% lower).
The record links to 2 conditions, with Cardiovascular Disease appearing as the primary indexed condition, and to 1 intervention - of which Tildrakizumab is the first listed.
NCT04271540 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT04271540 about?
NCT04271540 is a clinical study titled "MIcrovascular dysfuNction In Moderate-severe Psoriasis". Psoriasis, a common chronic inflammatory skin disease affecting approximately 2% of the population, is associated with increased cardiovascular (CV) risk. Despite the implication of inflammation in this excess risk, it remains unclear whether reducing inflammation reduces the risk of cardiac events....
What is the current status of trial NCT04271540?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 36 participants. The study started on 2020-04-04. Estimated completion is 2024-07-17.
What conditions does trial NCT04271540 study?
This clinical trial studies the following conditions: Cardiovascular Disease, Psoriasis.
What interventions are being tested in trial NCT04271540?
The interventions under investigation include: Tildrakizumab (DRUG).
Who is sponsoring clinical trial NCT04271540?
This trial is sponsored by Marcelo F. Di Carli, MD, FACC, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04271540 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT04271540's enrollment target sits among peer trials
36 123rd of 137 higher than 15 of 137 other Cardiovascular Disease trials
participants (enrollment target), bucketed by value
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