Psoriasis Clinical Trial

The Psoriasis, Atherosclerosis, and Cardiometabolic Disease Initiative (PACI)

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.

View Full Description

Full 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.

View Eligibility Criteria

Eligibility Criteria

INCLUSION CRITERIA
18 years of age or older
Diagnosed with psoriasis clinically confirmed by provider, consisting of typical skin findings and associated findings of systemic disease of joints, nails and hair)

EXCLUSION CRITERIA

For skin and adipose biopsy, any subject with known bleeding disorder, current fever or on anticoagulation.
Pregnant women and lactating women, may not undergo any study procedures until they are no longer pregnant or breast feeding.

Subjects with a contraindication to MRI scanning will not receive the optional PET/MRI. These contraindications include subjects with the following devices:

Central nervous system aneurysm clips
Implanted neural stimulator
Implanted cardiac pacemaker or defibrillator
Cochlear implant
Ocular foreign body (e.g. metal shavings)
Implanted Insulin pump
Metal shrapnel or bullet
Subjects with a BMI >45 will also not receive the PET MRI.
Subjects with severe renal excretory dysfunction, estimated glomerular filtration rate < 30 mL/min/1.73m^2 body surface area according to the Modification of Diet in Renal Disease criteria, will not receive the cardiac CT angiography, or gadolinium contrast agent during the PET/MRI.

Study is for people with:

Psoriasis

Estimated Enrollment:

386

Study ID:

NCT01778569

Recruitment Status:

Completed

Sponsor:

National Heart, Lung, and Blood Institute (NHLBI)

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There is 1 Location for this study

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National Institutes of Health Clinical Center
Bethesda Maryland, 20892, United States

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Estimated Enrollment:

386

Study ID:

NCT01778569

Recruitment Status:

Completed

Sponsor:


National Heart, Lung, and Blood Institute (NHLBI)

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