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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by National Institutes of Health Clinical Center (CC)
University of Pennsylvania
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) ) Identifier:
First received: January 26, 2013
Last updated: September 2, 2015
Last verified: November 2014


- 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.


- To study the relationship between psoriasis and cardiometabolic diseases.


- Individuals at least 18 years of age who have psoriasis.


  • 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.

Metabolic Disease
Cardiovascular Disease

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


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
  • 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)


  • 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.
  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 identifier: NCT01778569

Contact: Dorothy J Tripodi, R.N. (301) 496-3431
Contact: Nehal N Mehta, M.D. (301) 827-0483

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   
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104-6056
Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
University of Pennsylvania
Principal Investigator: Nehal N Mehta, M.D. National Heart, Lung, and Blood Institute (NHLBI)
  More Information

Additional Information:
Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) ) Identifier: NCT01778569     History of Changes
Other Study ID Numbers: 130065, 13-H-0065
Study First Received: January 26, 2013
Last Updated: September 2, 2015
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Cardiovascular Diseases
Metabolic Diseases
Arterial Occlusive Diseases
Skin Diseases
Skin Diseases, Papulosquamous
Vascular Diseases
Pathologic Processes processed this record on October 07, 2015