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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by National Institutes of Health Clinical Center (CC)
Sponsor:
Collaborator:
University of Pennsylvania
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )
ClinicalTrials.gov Identifier:
NCT01778569
First received: January 26, 2013
Last updated: March 14, 2014
Last verified: November 2013
  Purpose

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 and 3 will be 6 and 12 months after visit 1. Visits 4, 5, and 6 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, 3, and 6, 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 2, 4, and 5, participants will have a physical exam and medical history. They will also provide blood and urine samples, and have heart function tests.

Condition
Metabolic Disease
Cardiovascular Disease
Inflammation

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Human Translational Studies of Inflammation and Cardiometabolic Diseases: The Psoriasis, Atherosclerosis and Cardiometabolic Disease (PACI) Initiative

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • Our primary outcome of interest is vascular inflammation measured by standard uptake values from PET-CT imaging with FDG. [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1200
Study Start Date: January 2013
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • 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/1.73m2 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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01778569

Contacts
Contact: Dorothy J Tripodi, R.N. (301) 496-3431 tripodid@nhlbi.nih.gov
Contact: Nehal N Mehta, M.D. (301) 827-0483 mehtann@mail.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010    prpl@mail.cc.nih.gov   
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104-6056
Sponsors and Collaborators
University of Pennsylvania
Investigators
Principal Investigator: Nehal N Mehta, M.D. National Heart, Lung, and Blood Institute (NHLBI)
  More Information

Additional Information:
Publications:
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )
ClinicalTrials.gov Identifier: NCT01778569     History of Changes
Other Study ID Numbers: 130065, 13-H-0065
Study First Received: January 26, 2013
Last Updated: March 14, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Psoriasis
Cardiovascular Risk Factors
Inflammation
Lipoproteins
Metabolic Dysfunction

Additional relevant MeSH terms:
Atherosclerosis
Arteriosclerosis
Cardiovascular Diseases
Inflammation
Metabolic Diseases
Psoriasis
Arterial Occlusive Diseases
Vascular Diseases
Pathologic Processes
Skin Diseases, Papulosquamous
Skin Diseases

ClinicalTrials.gov processed this record on August 27, 2014