Determining Disease Activity Biomarkers in Individuals With Takayasu's Arteritis

Last updated: July 11, 2022
Sponsor: University of Pennsylvania
Overall Status: Completed

Phase

N/A

Condition

Vascular Diseases

Collagen Vascular Diseases

Circulation Disorders

Treatment

N/A

Clinical Study ID

NCT00315471
VCRC5503
U54AR057319
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Evidence of arteriogram abnormalities compatible with Takayasu's arteritis (includesconventional dye angiography, magnetic resonance angiography, or computed tomographyangiography)
  • Evidence of one of the following criteria:
  1. Age at disease onset of 50 years or younger
  2. Claudication of the arms or legs
  3. Decreased brachial artery pulse (one or both arteries)
  4. Blood pressure difference between the arms of at least 10 mm Hg
  5. Bruit over the subclavian arteries or aorta
  • Parental consent for children under the age of 18

Exclusion

Exclusion Criteria:

  • Arteriographic lesions that could be entirely due to atherosclerosis
  • Fibromuscular dysplasia
  • Cogan's syndrome
  • Behcet's disease
  • Sarcoidosis
  • Kawasaki disease
  • Giant cell arteritis (large vessel vasculitis and at least 50 years old)
  • Syphilis or other infectious forms of large vessel vasculitis

Study Design

Total Participants: 224
Study Start date:
April 01, 2006
Estimated Completion Date:
December 31, 2019

Study Description

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.

Connect with a study center

  • St. Joseph's Healthcare

    Hamilton, Ontario
    Canada

    Site Not Available

  • Mount Sinai Hospital

    Toronto, Ontario M5T 3L9
    Canada

    Site Not Available

  • The Johns Hopkins Vasculitis Center

    Baltimore, Maryland 21224
    United States

    Site Not Available

  • Boston University School of Medicine

    Boston, Massachusetts 02118
    United States

    Site Not Available

  • Brigham and Women's Hospital

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Mayo Clinic College of Medicine

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Cleveland Clinic Foundation

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • University of Pittsburgh

    Pittsburgh, Pennsylvania 15260
    United States

    Site Not Available

  • University of Utah

    Salt Lake City, Utah 84112
    United States

    Site Not Available

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