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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01778569
Other study ID # 130065
Secondary ID 13-H-0065
Status Recruiting
Phase
First received
Last updated
Start date January 22, 2013
Est. completion date June 30, 2030

Study information

Verified date September 21, 2021
Source National Institutes of Health Clinical Center (CC)
Contact Tania R Machado
Phone (301) 661-1505
Email tania.machado@nih.gov
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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 information / eligibility

Status Recruiting
Enrollment 1200
Est. completion date June 30, 2030
Est. primary completion date June 30, 2030
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility - 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. - For imaging studies, pregnant women and lactating women, unless they are willing to discard breast milk for 24 hours after receiving FDG or contrast - 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 Design


Locations

Country Name City State
United States National Institutes of Health Clinical Center, 9000 Rockville Pike Bethesda Maryland

Sponsors (1)

Lead Sponsor Collaborator
National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Our primary outcome of interest is vascular inflammation measured by standard uptake values from PET-CT imaging with FDG. vascular inflammation measured by standard uptake values from PET-CT imaging with FDG. 4-6 years
Secondary Mean Aortic Wall Thickness 4-6 years
Secondary Coronary Artery Calcium Score 4-6 years
Secondary HDL function 4-6 years
Secondary lipoprotein particle size and number 4-6 years
Secondary immune, metabolic &amp; inflammation measure 4-6 years
Secondary Myocardial Flow Reserve (MFR) 4-6 years
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