Status:
COMPLETED
MIcrovascular dysfuNction In Moderate-severe Psoriasis
Lead Sponsor:
Marcelo F. Di Carli, MD, FACC
Conditions:
Psoriasis
Cardiovascular Disease
Eligibility:
All Genders
18-90 years
Phase:
PHASE4
Brief 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 th...
Detailed Description
The primary objective of this study is to investigate the impact of Tildrakizumab therapy on coronary vasoreactivity and myocardial mechanics, as indicators of subclinical cardiovascular disease in pa...
Eligibility Criteria
Inclusion
- In order for an individual to participate, they must meet all of the inclusion and exclusion criteria as outlined below.
- Inclusion Criteria include the following:
- Moderate-to-severe psoriasis
- Ages 18-90
- Body surface area (BSA) involvement ≥ 3% OR 5-point Physician Global Assessment (PGA) Score ≥ 3 OR Psoriasis Area and Severity Index (PASI) score ≥ 12
- Patients who have failed biologic therapy, topical steroids, phototherapy, or other systemic therapies will be required to have a wash-out period, which will be calculated accordingly to the specific drug (Appendix 1)
- Evidence of at least one cardiovascular risk factor which includes hsCRP ≥ 2 mg/L, DM, obesity (BMI\>25), hyperlipidemia, hypertension, family history of early coronary artery disease, or evidence of metabolic syndrome
- --Metabolic syndrome defined as at least three of the following: glucose\>100mg/dl or taking hypoglycemic agent, HDL\<40mg/dl (men) or 50 mg/dl (women), triglycerides ≥150mg/dl, waist circumference \>40 in mean or \>35 in women, or blood pressure ≥130/85 or taking anti-hypertensive.
- If the patient is on a statin therapy, they must be on a stable dose for at least 6 months prior to enrollment.
- Exclusion Criteria include the following:
- Documented history of other systemic inflammatory diseases, including SLE and RA, which in the opinion of the investigator would be inappropriate for enrollment.
- Prior history of untreated chronic infection (tuberculosis), severe fungal infection, or known HIV positive, chronic hepatitis B or C infection), prior history of active solid malignancy, myeloproliferative or lymphoproliferative disease within 5 years, excluding treated non-melanoma skin cancer
- Renal insufficiency (CrCl \<40 ml/min)
- NYHA class IV heart failure
- Patients requiring chronic treatment with oral prednisone \>10mg/day, methotrexate, or other immunosuppressive agents.
- Pregnancy and Breastfeeding
Exclusion
Key Trial Info
Start Date :
April 4 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 17 2024
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT04271540
Start Date
April 4 2020
End Date
July 17 2024
Last Update
November 25 2025
Active Locations (1)
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1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115