The Psoriasis, Atherosclerosis, and Cardiometabolic Disease Initiative (PACI)
- Conditions
- PsoriasisCardiovascular DiseaseInflammationMetabolic Disease
- Registration Number
- NCT01778569
- Brief Summary
Background:
- Cardiometabolic diseases are medical disorders that can occur together and affect the heart. They increase the risk of developing heart disease and diabetes. One disorder, psoriasis, is an inflammation that mostly affects the skin but can affect the entire body. Another disorder, atherosclerosis, is a process in which cholesterol is gradually deposited on the wall of arteries. This causes arteries to harden and become less flexible. Many cells that cause psoriasis also cause atherosclerosis. Researchers want to look at the relationship between cardiometabolic diseases and psoriasis.
Objectives:
- To study the relationship between psoriasis and cardiometabolic diseases.
Eligibility:
- Individuals at least 18 years of age who have psoriasis.
Design:
* Participants will be screened with a physical exam and medical history.
* Participants will have up to seven outpatient visits over the 4 years. The first visit will be a screening visit. Visits 2 will be12 months after visit 1. Visits 3, 4, and 5, will be scheduled yearly for the next 3 years. If participants have a psoriasis flare with more severe symptoms, they may have an extra visit. Those who leave the study early will have a final visit with the full series of tests.
* At visits 1, 2,and 5, and any flare visits, participants will have a physical exam and medical history. They will provide blood and urine samples, as well as optional tissue biopsies. They will also have heart function tests. Imaging studies, as well as optional photographs of affected areas, will be performed. These tests will also be performed at the final visit.
* At visits 3 and 4, participants will have a physical exam and medical history. They will also provide blood and urine samples, and have heart function tests.
- Detailed Description
Over the past two decades, inflammation has been identified as an important pathogenic process in cardiometabolic diseases (CMD) such atherosclerotic cardiovascular disease (CVD), dyslipidemia, insulin resistance, diabetes and obesity. However, mechanistic links between inflammation and these disease states in humans remain poorly understood. In this study, we propose to utilize psoriasis, a common, chronic inflammatory T-cell skin disease associated with increased CVD and CMD as a model to understand the effect of chronic inflammation on these diseases states. We will conduct a prospective cohort study to understand the effect of chronic inflammation on vascular and metabolic disease at the NIH Clinical Center. Furthermore, we will initiate a large scale collection of blood and skin from extramural sites to facilitate discovery of pathways involved in inflammatory modulation of CVD and CMD.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 386
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Our primary outcome of interest is vascular inflammation measured by standard uptake values from PET-CT imaging with FDG. 4-6 years vascular inflammation measured by standard uptake values from PET-CT imaging with FDG.
- Secondary Outcome Measures
Name Time Method Mean Aortic Wall Thickness 4-6 years lipoprotein particle size and number 4-6 years immune, metabolic & inflammation measure 4-6 years Coronary Artery Calcium Score 4-6 years Myocardial Flow Reserve (MFR) 4-6 years HDL function 4-6 years
Trial Locations
- Locations (1)
National Institutes of Health Clinical Center
🇺🇸Bethesda, Maryland, United States