Clinical Trial: Determining Disease Activity Biomarkers in Individuals With Takayasu's Arteritis
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational
Official Title: VCRC Longitudinal Protocol for Takayasu's Arteritis
Brief Summary: Takayasu's arteritis is a rare disorder that causes swelling and damage to the large arteries in the body, such as the aorta. In order to ensure proper treatment, measuring disease activity is critical. The purpose of this study is to establish new biological markers (biomarkers) to assess the severity of disease in people with Takayasu's arteritis.
Detailed Summary:
Takayasu's arteritis is a chronic inflammatory condition that affects the aorta, the largest blood vessel in the body, and its branches. Inflammation causes segments of the vessels to become narrowed, blocked, or even stretched, possibly resulting in aneurysms. The disease is very rare but most commonly occurs in young Asian women. Symptoms may include arm pain with use, decreased or absent pulses, lightheadedness or dizziness, headaches, and visual disturbances. Many individuals with Takayasu' arteritis, however, have no apparent symptoms despite disease activity. Additionally, current tests used to measure vessel inflammation are considered unreliable and inconsistent. It is therefore very difficult to determine the extent of disease activity in a person with Takayasu's arteritis. This study will use novel scientific methods to establish new biomarkers that can be used to monitor disease activity in individuals with Takayasu's arteritis. These biomarkers may be used to help direct clinical care and assist in future drug development.
Study visits will occur monthly for the first year, then every 3 months thereafter for the remainder of the study. Blood and urine collection will occur at every visit. A physical examination, disease assessment, and review of medications will occur every 3 months; participants may also be asked to complete various questionnaires. Diagnostic testing, which may include chest radiograph, echocardiogram, magnetic resonance imaging, or angiography, will occur every 6 months. Tobacco, alcohol, and drug use will be assessed on a yearly basis. Participants may have additional study visits if a disease flare or disease-related complications occur during the study.
Sponsor: University of Pennsylvania
Current Primary Outcome: Discover biomarkers in Takayasu's arteritis capable of measuring disease activity and response to treatment. [ Time Frame: Study completion ]
Original Primary Outcome:
Current Secondary Outcome: Measure the predictive value of biomarkers for clinical outcome in Takayasu's arteritis. [ Time Frame: Study completion. ]
Original Secondary Outcome:
Information By: University of Pennsylvania
Dates:
Date Received: April 14, 2006
Date Started: April 2006
Date Completion: April 2019
Last Updated: May 1, 2017
Last Verified: May 2017
