The Psoriasis, Atherosclerosis, and Cardiometabolic Disease Initiative (PACI)
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ClinicalTrials.gov Identifier: NCT01778569 |
Recruitment Status :
Recruiting
First Posted : January 29, 2013
Last Update Posted : May 25, 2022
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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 or disease |
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Metabolic Disease Cardiovascular Disease Inflammation Psoriasis |
Study Type : | Observational |
Estimated Enrollment : | 1200 participants |
Observational Model: | Case-Only |
Time Perspective: | Prospective |
Official Title: | Human Translational Studies of Inflammation and Cardiometabolic Diseases: The Psoriasis, Atherosclerosis and Cardiometabolic Disease (PACI) Initiative |
Actual Study Start Date : | January 22, 2013 |
Estimated Primary Completion Date : | June 30, 2030 |
Estimated Study Completion Date : | June 30, 2030 |

Group/Cohort |
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Group 1
Patient with a diagnosis of chronic plaque psoriasis, psoriatic arthritis, or pustular psoriasis
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- Our primary outcome of interest is vascular inflammation measured by standard uptake values from PET-CT imaging with FDG. [ Time Frame: 4-6 years ]vascular inflammation measured by standard uptake values from PET-CT imaging with FDG.
- Mean Aortic Wall Thickness [ Time Frame: 4-6 years ]
- Coronary Artery Calcium Score [ Time Frame: 4-6 years ]
- HDL function [ Time Frame: 4-6 years ]
- lipoprotein particle size and number [ Time Frame: 4-6 years ]
- immune, metabolic & inflammation measure [ Time Frame: 4-6 years ]
- Myocardial Flow Reserve (MFR) [ Time Frame: 4-6 years ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
- 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
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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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01778569
Contact: Tania R Machado | (301) 661-1505 | tania.machado@nih.gov | |
Contact: Nehal N Mehta, M.D. | (301) 827-0473 | mehtann@mail.nih.gov |
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 Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 prpl@cc.nih.gov |
Principal Investigator: | Nehal N Mehta, M.D. | National Heart, Lung, and Blood Institute (NHLBI) |
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 |
Other Study ID Numbers: |
130065 13-H-0065 |
First Posted: | January 29, 2013 Key Record Dates |
Last Update Posted: | May 25, 2022 |
Last Verified: | May 6, 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Imaging Cardiovascular Risk Factors Inflammation |
Lipoproteins Metabolic Dysfunction Natural History |
Cardiovascular Diseases Atherosclerosis Psoriasis Metabolic Diseases Inflammation Pathologic Processes |
Skin Diseases, Papulosquamous Skin Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases |