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- Study Description
Takayasu's arteritis is a rare disease that affects the blood vessels. Takayasu's arteritis can cause swelling of large and medium-sized blood vessels. The blood vessels that are commonly affected are the branches of the aorta (the main blood vessel that leaves the heart). The purpose of this study is to help doctors learn more about this disease by using x-ray like tests to see if they are helpful in taking care of patients with Takayasu's arteritis.
This is an imaging study that compares x-ray-like tests that would not be a part of your regular care (PET/CT) with x-ray-like tests that are a part of your regular care (MRI). At two visits, three months apart, patients will have a PET/CT scan performed at the same time as their MRI scan; some patients will also have a third PET/CT scan. A total of 36 people with Takayasu's arteritis at several hospitals will take part in this study. Doctors will use images from the different time points, along with information from exams and symptoms, to learn more about the disease.
- Study Weblinks:
- Study Design:
- Prospective Longitudinal Cohort
- Study Type:
- Clinical Trial
- Authorized Access
- Publicly Available Data (Public ftp)
- Study Inclusion/Exclusion Criteria
- A diagnosis of Takayasu's arteritis as defined by the VCRC Longitudinal Study #5503 and concurrent enrollment in the VCRC Longitudinal Study #5503.
- Age: ≥ 18 years of age. The PET studies will be limited to people ≥ 18 years of age years to a) avoid the extra exposure of CT/PET in younger children; b) preclude the need for sedation and thus increased risk for younger children; c) avoid concerns that the semi-quantitative measures of PET and MR signals will be non-comparable between small children and adults. Note: Takayasu's arteritis is quite rare in young children.
- Within 2 weeks prior to enrollment, participants must have had active disease occurring in conjunction with a disease relapse. Active disease will be defined by the presence of clinical features or imaging or both: Clinical features:
The new, recurrent, or worsening presence of one or more of the following that cannot be attributed to any cause other than TAK and would usually prompt treatment or additional treatment:
- Sustained fever of > 38º C for > 1 week
- Vascular pain/tenderness producing symptoms such as carotidynia, scalp tenderness, or temporal artery abnormalities (tenderness or nodularity). Such vascular symptoms should be present for more than one day and be non-fleeting.
- Headache that is a) present for more than one day; b) non-fleeting; c) not fully relieved with non-narcotic analgesics; and d) not typical for any pre-existing form of headaches the patient may have experienced (such as migraines or tension headaches).
- Ischemic retinopathy, optic neuropathy, or visual loss
- Tongue/jaw claudication
- Transient cerebral ischemia or stroke
- Extremity claudication
- Musculoskeletal symptoms (with inflammatory features including joint swelling or morning stiffness) in combination with an ESR of > 40 mm in the first hour by the Westergren method or a CRP measurement above the laboratory normal limit
- Malaise and fatigue in combination with an ESR of > 40 mm in the first hour by the Westergren method or a CRP measurement above the laboratory normal limit
- Other symptoms/signs attributed by the investigator to TAK that necessitate reinstitution or increase in glucocorticoids (GC) for the treatment of TAK
- Willingness and ability to comply with the schedule for imaging study and follow-up procedures.
- Willingness and ability to provide informed consent.
- Participants who are pregnant or who are nursing infants. Women of childbearing potential will undergo a pregnancy test prior to imaging.
- Inability to comply with study guidelines.
- Inability to safely undergo MRI scanning.
- Study History
- Study Activated August 28, 2008
- First Accrual October 7, 2008
- Selected publications
- Diseases/Traits Related to Study (MeSH terms)
- Links to Related Resources
- Authorized Data Access Requests
- Study Attribution
- Peter A. Merkel, MD, MPH. University of Pennsylvania, Philadelphia, PA, USA.
Participating Site Principal Investigators
- Paul Monach, MD, PhD. Boston University School of Medicine, Boston, MA, USA.
- Carol Langford, MD, MHS. Cleveland Clinic, Cleveland, OH, USA.
- Steven Ytterberg, MD. Mayo Clinic, Rochester, MN, USA.
- Simon Carette, MD. Mount Sinai Hospital, Toronto, ON, Canada.
- Nader Khalidi, MD. St. Joseph's Healthcare Hamilton, Hamilton, ON, Canada.
- Jeffrey P. Krischer, PhD. Data Management and Coordinating Center, University of South Florida, Tampa, FL, USA.
Current Funding Sources
- U54-AR057319. National Institutes of Health, Bethesda, MD, USA.
- Study Chairs