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Protocol Details

Human Translational Studies of Inflammation and Cardiometabolic Diseases: The Psoriasis, Atherosclerosis and Cardiometabolic Disease (PACI) Initiative

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

13-H-0065

Sponsoring Institute

National Heart, Lung and Blood Institute (NHLBI)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18 Years
Max Age: N/A

Referral Letter Required

No

Population Exclusion(s)

Children

Special Instructions

Currently Not Provided

Keywords

Imaging;
Cardiovascular Risk Factors;
Inflammation;
Lipoproteins;
Metabolic Dysfunction

Recruitment Keyword(s)

None

Condition(s)

Metabolic Disease;
Cardiovascular Disease;
Inflammation;
Psoriasis

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Heart, Lung and Blood InstituteNational Heart, Lung, and Blood Institute

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.

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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.


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Nehal N. Mehta, M.D.
National Heart, Lung and Blood Institute (NHLBI)
BG 10-CRC RM 5-3142
10 CENTER DR
BETHESDA MD 20814
(301) 827-0473
mehtann@mail.nih.gov

Tania R. Machado
National Heart, Lung and Blood Institute (NHLBI)
National Institutes of Health
Building 10
Room 6D03
10 Center Drive
Bethesda, Maryland 20892
(301) 661-1505
tania.machado@nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: 1-866-411-1010
PRPL@cc.nih.gov

Clinical Trials Number:

NCT01778569

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