The Psoriasis, Atherosclerosis, and Cardiometabolic Disease Initiative (PACI)
This study is currently recruiting participants.
(see Contacts and Locations)
Verified July 2016 by National Institutes of Health Clinical Center (CC)
Sponsor:
National Heart, Lung, and Blood Institute (NHLBI)
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: August 31, 2016
Last verified: July 2016
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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 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.
| 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 2022 |
| Estimated Primary Completion Date: | June 2018 (Final data collection date for primary outcome measure) |
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 (Adult, Senior) |
| 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/1.73m^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 ClinicalTrials.gov identifier: NCT01778569
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 | |
Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
| Principal Investigator: | Nehal N Mehta, M.D. | National Heart, Lung, and Blood Institute (NHLBI) |
More Information
Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | 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: | August 31, 2016 |
| 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:
|
Inflammation Cardiovascular Diseases Psoriasis Atherosclerosis Metabolic Diseases Pathologic Processes |
Skin Diseases, Papulosquamous Skin Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases |
ClinicalTrials.gov processed this record on September 29, 2016