Determining Disease Activity Biomarkers in Individuals With Takayasu's Arteritis

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by University of Pennsylvania
Sponsor:
Collaborators:
Rare Diseases Clinical Research Network
Information provided by (Responsible Party):
Peter Merkel, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00315471
First received: April 14, 2006
Last updated: November 22, 2013
Last verified: November 2013
  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

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Discover biomarkers in Takayasu's arteritis capable of measuring disease activity and response to treatment. [ Time Frame: Study completion ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Measure the predictive value of biomarkers for clinical outcome in Takayasu's arteritis. [ Time Frame: Study completion. ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

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)
Detailed 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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Individuals with Takayasu's arteritis. Enrollment will be sequential and participants will have disease in various stages and of different duration.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00315471

Locations
United States, Massachusetts
Boston University School of Medicine Recruiting
Boston, Massachusetts, United States, 02118
Contact: Naomi Amudala    617-414-2512    namudala@bu.edu   
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: Brian Rice    215-614-4407    Brian.Rice@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         
Sponsors and Collaborators
University of Pennsylvania
Rare Diseases Clinical Research Network
Investigators
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: November 22, 2013
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 October 19, 2014