NCT01778569

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

Completed Last updated 16 April 2026

What this trial tests

trial in Metabolic Disease in 386 participants. Completed.

Timeline

22 January 2013

Primary endpoint
6 January 2023

Quick facts

Lead sponsor	National Heart, Lung, and Blood Institute (NHLBI)
Status	Completed
Study type	OBSERVATIONAL
Enrollment	386
Start date	22 January 2013
Primary completion	6 January 2023
Sites	1 location across United States

Conditions studied

• Metabolic Disease — all drugs for Metabolic Disease →
• Cardiovascular Disease — all drugs for Cardiovascular Disease →
• Inflammation — all drugs for Inflammation →
• Psoriasis — all drugs for Psoriasis →

Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Who can join

Adults 18 to 99, any sex, with Metabolic Disease or Cardiovascular Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Severity of Psoriasis Associates With Aortic Vascular Inflammation Detected by FDG PET/CT and Neutrophil Activation in a Prospective Observational Study.
   Naik HB, Natarajan B, Stansky E, Ahlman MA, et al · · 2015 · cited 147× · PMID 26449753 · DOI 10.1161/atvbaha.115.306460
2. The relationship between duration of psoriasis, vascular inflammation, and cardiovascular events.
   Egeberg A, Skov L, Joshi AA, Mallbris L, et al · · 2017 · cited 89× · PMID 28826925 · DOI 10.1016/j.jaad.2017.06.028
3. Chronic Stress-Related Neural Activity Associates With Subclinical Cardiovascular Disease in Psoriasis: A Prospective Cohort Study.
   Goyal A, Dey AK, Chaturvedi A, Elnabawi YA, et al · · 2020 · cited 68× · PMID 30448131 · DOI 10.1016/j.jcmg.2018.08.038
4. A systems approach for discovering linoleic acid derivatives that potentially mediate pain and itch.
   Ramsden CE, Domenichiello AF, Yuan ZX, Sapio MR, et al · · 2017 · cited 67× · PMID 28831021 · DOI 10.1126/scisignal.aal5241
5. Cholesterol efflux capacity in humans with psoriasis is inversely related to non-calcified burden of coronary atherosclerosis.
   Salahuddin T, Natarajan B, Playford MP, Joshi AA, et al · · 2015 · cited 60× · PMID 26188212 · DOI 10.1093/eurheartj/ehv339
6. Psoriatic arthritis and sacroiliitis are associated with increased vascular inflammation by 18-fluorodeoxyglucose positron emission tomography computed tomography: baseline report from the Psoriasis Atherosclerosis and Cardiometabolic Disease Initiative.
   Rose S, Dave J, Millo C, Naik HB, et al · · 2014 · cited 30× · PMID 25078679 · DOI 10.1186/ar4676
7. Characterization of immune cells in psoriatic adipose tissue.
   Rose S, Stansky E, Dagur PK, Samsel L, et al · · 2014 · cited 23× · PMID 25224267 · DOI 10.1186/s12967-014-0258-2
8. Chronic inflammation in psoriasis promotes visceral adiposity associated with noncalcified coronary burden over time.
   Sajja A, Abdelrahman KM, Reddy AS, Dey AK, et al · · 2020 · cited 22× · PMID 33104056 · DOI 10.1172/jci.insight.142534