The Psoriasis, Atherosclerosis, and Cardiometabolic Disease Initiative (PACI)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01778569|
Recruitment Status : Recruiting
First Posted : January 29, 2013
Last Update Posted : September 5, 2019
- 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 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|
|Metabolic Disease Cardiovascular Disease Inflammation Psoriasis|
|Study Type :||Observational|
|Estimated Enrollment :||1200 participants|
|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|
Patient with a diagnosis of chronic plaque psoriasis, psoriatic arthritis, or pustular psoriasis
- Our primary outcome of interest is vascular inflammation measured by standard uptake values from PET-CT imaging with FDG. [ Time Frame: 4 years ]Vascular inflammation measured by standard uptake values from PET-CT imaging with FDG.
- Mean Aortic Wall Thickness [ Time Frame: 4 years ]
- Coronary Artery Calcium Score [ Time Frame: 4 years ]
- HDL Function [ Time Frame: 4 years ]
- Lipoprotein particle size and number [ Time Frame: 4 years ]
- Immune, metabolic &inflammation measure [ Time Frame: 4 years ]
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: Andrew Keel, R.N.||(301) email@example.com|
|Contact: Nehal N Mehta, M.D.||(301) firstname.lastname@example.org|
|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 email@example.com|
|Principal Investigator:||Nehal N Mehta, M.D.||National Heart, Lung, and Blood Institute (NHLBI)|