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NCT01778569 · ClinicalTrials.gov registry record
The Psoriasis, Atherosclerosis, and Cardiometabolic Disease Initiative (PACI)
A clinical trial, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- Completed
- Registry status
- 386
- Enrollment target
NCT01778569: Completed study, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
NCT01778569 is a clinical trial that has completed, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 386 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01778569 has completed, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- COMPLETED
- Registry status
- 386 participants
- Enrollment target
Study Summary
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.
Primary Outcome
vascular inflammation measured by standard uptake values from PET-CT imaging with FDG.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 386 participants |
| Start Date | 2013-01-22 |
What the finished NCT01778569 record still lists
NCT01778569 is an observational study that tracks outcomes without assigning an intervention. The registered 386 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT01778569 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01778569 about?
NCT01778569 is a clinical study titled "The Psoriasis, Atherosclerosis, and Cardiometabolic Disease Initiative (PACI)". 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, ath...
What is the current status of trial NCT01778569?
This trial is currently completed. The enrollment target is 386 participants. The study started on 2013-01-22.
Who is sponsoring clinical trial NCT01778569?
This trial is sponsored by National Heart, Lung, and Blood Institute (NHLBI), which has 501 total clinical trials registered on ClinicalTrials.gov.
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