Determining Disease Activity Biomarkers in Individuals With Takayasu's Arteritis
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Purpose
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.
| Condition |
|---|
|
Takayasu's Arteritis |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | VCRC Longitudinal Protocol for Takayasu's Arteritis |
Blood (serum and plasma), urine, and DNA
| Estimated Enrollment: | 250 |
| Study Start Date: | April 2006 |
| Estimated Study Completion Date: | April 2016 |
| Estimated Primary Completion Date: | April 2016 (Final data collection date for primary outcome measure) |
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Individuals with Takayasu's arteritis. Enrollment will be sequential and participants will have disease in various stages and of different duration.
Inclusion Criteria:
- Evidence of arteriogram abnormalities compatible with Takayasu's arteritis (includes conventional dye angiography, magnetic resonance angiography, or computed tomography angiography)
Evidence of one of the following criteria:
- Age at disease onset of 50 years or younger
- Claudication of the arms or legs
- Decreased brachial artery pulse (one or both arteries)
- Blood pressure difference between the arms of at least 10 mm Hg
- Bruit over the subclavian arteries or aorta
- Parental consent for children under the age of 18
Exclusion Criteria:
- Arteriographic lesions that could be entirely due to atherosclerosis
- Fibromuscular dysplasia
- Cogan's syndrome
- Behcet's disease
- Sarcoidosis
- Kawasaki's disease
- Giant cell arteritis (large vessel vasculitis and at least 50 years old)
- Syphilis or other infectious forms of large vessel vasculitis
Contacts and Locations| United States, Maryland | |
| The Johns Hopkins Vasculitis Center | Active, not recruiting |
| Baltimore, Maryland, United States, 21224 | |
| United States, Massachusetts | |
| Boston University School of Medicine | Recruiting |
| Boston, Massachusetts, United States, 02118 | |
| Contact: Daniel Finkel 617-414-2509 | |
| Principal Investigator: Paul A. Monach, MD, PhD | |
| United States, Minnesota | |
| Mayo Clinic College of Medicine | Recruiting |
| Rochester, Minnesota, United States, 55905 | |
| Contact: Jane Jaquith jaquith.jane@mayo.edu | |
| Principal Investigator: Steven R. Ytterberg, MD | |
| United States, Ohio | |
| Cleveland Clinic Foundation | Recruiting |
| Cleveland, Ohio, United States, 44195 | |
| Contact: Katie Gartner 216-445-1397 gartnek@ccf.org | |
| Principal Investigator: Carol A. Langford, MD, MHS | |
| United States, Pennsylvania | |
| University of Pennsylvania | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Contact: Alex Giardino 215-614-4407 Alexandra.Giardino@uphs.upenn.edu; | |
| Principal Investigator: Peter Merkel, MD, MPH | |
| University of Pittsburgh | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15260 | |
| Contact: Dawn McBride, RN 412-586-3545 dlmc@pitt.edu | |
| Principal Investigator: Larry Moreland, MD | |
| United States, Utah | |
| University of Utah | Recruiting |
| Salt Lake City, Utah, United States, 84112 | |
| Contact: Jennifer Godina 801-581-4993 Jennifer.Godina@hsc.utah.edu | |
| Principal Investigator: Curry Koening, MD, MHS | |
| Canada, Ontario | |
| St. Joseph's Healthcare | Recruiting |
| Hamilton, Ontario, Canada | |
| Contact: Sandra Messier 905-522-1155 ext 35873 smessier@stjoes.ca | |
| Principal Investigator: Nader A. Khalidi, MD | |
| Mount Sinai Hospital | Recruiting |
| Toronto, Ontario, Canada, M5T 3L9 | |
| Contact: Julia Farquharson 416-586-8616 JFarquharson@mtsinai.on.ca | |
| Principal Investigator: Simon Carette, MD | |
| Study Director: | Peter A. Merkel, MD, MPH | Vasculitis Clinical Research Consortium (VCRC) |
More Information
Additional Information:
Publications:
| Responsible Party: | Peter Merkel, Professor, University of Pennsylvania |
| ClinicalTrials.gov Identifier: | NCT00315471 History of Changes |
| Other Study ID Numbers: | RDCRN 5503, U54AR057319 |
| Study First Received: | April 14, 2006 |
| Last Updated: | October 23, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by University of Pennsylvania:
|
Vasculitis |
Additional relevant MeSH terms:
|
Arteritis Takayasu Arteritis Aortic Arch Syndromes Vascular Diseases Cardiovascular Diseases |
Vasculitis Aortic Diseases Skin Diseases, Vascular Skin Diseases |
ClinicalTrials.gov processed this record on May 22, 2013