Determining Disease Activity Biomarkers in Individuals With Takayasu's Arteritis



Status:Recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:Any
Updated:3/27/2019
Start Date:April 2006
End Date:April 2019

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VCRC Longitudinal Protocol for Takayasu's Arteritis

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.

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.

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:

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 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
We found this trial at
8
sites
2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Principal Investigator: Carol A. Langford, MD, MHS
Phone: 216-445-1397
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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Cleveland, OH
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72 East Concord Street
Boston, Massachusetts 02118
(617) 638-5300
Principal Investigator: Paul A. Monach, MD, PhD
Phone: 617-414-2512
Boston University School of Medicine A leader in medical education and research, Boston University School...
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Boston, MA
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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Boston, MA
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4200 Fifth Ave
Pittsburgh, Pennsylvania 15260
(412) 624-4141
Principal Investigator: Larry Moreland, MD
University of Pittsburgh The University of Pittsburgh is a state-related research university, founded as the...
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Pittsburgh, PA
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201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
Principal Investigator: Curry Koening, MD, MHS
Phone: 801-581-4993
University of Utah Research is a major component in the life of the U benefiting...
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Salt Lake City, UT
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Hamilton, Ontario
Principal Investigator: Nader A. Khalidi, MD
Phone: 905-522-1155
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Hamilton,
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Principal Investigator: Peter Merkel, MD, MPH
Phone: 215-614-4407
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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Philadelphia, PA
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200 1st St SW
Rochester, Minnesota 55905
(507) 284-2316
Principal Investigator: Steven R. Ytterberg, MD
Mayo Clinic College of Medicine Mayo Medical School enrolls a select class of 50 medical...
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Rochester, MN
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