The Psoriasis, Atherosclerosis, and Cardiometabolic Disease Initiative (PACI)
| Status: | Recruiting |
|---|---|
| Conditions: | Peripheral Vascular Disease, Psoriasis, Cardiology, Endocrine |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Dermatology / Plastic Surgery, Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 110 |
| Updated: | 12/21/2018 |
| Start Date: | January 22, 2013 |
| End Date: | June 30, 2020 |
| Contact: | Andrew Keel, R.N. |
| Email: | akeel@cc.nih.gov |
| Phone: | (301) 827-0324 |
Human Translational Studies of Inflammation and Cardiometabolic Diseases: The Psoriasis, Atherosclerosis and Cardiometabolic Disease (PACI) Initiative
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.
- 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.
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
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
- INCLUSION CRITERIA
- 18 years of age or older
- Diagnosed with psoriasis clinically confirmed by an expert physician, 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 >40 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.
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
Phone: 800-411-1222
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