VCRC5503: Longitudinal Protocol for Takayasu's Arteritis

The development and validation of accurate biological markers and predictors of disease activity and outcome for Takayasu's arteritis, a form of idiopathic vasculitis, would have a major positive impact on the clinical care of patients with this rare disease, be an important advance in the design of clinical trials and feasibility of new drug development, and provide important insight into the pathogenesis of this condition. Current measures of disease activity, including erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP), while helpful in selected settings, are mostly considered highly flawed and markers whose poor correlation with disease flares makes them inadequate to help guide therapy. Similarly, ESR and CRP are clearly unhelpful as diagnostic tests for vasculitis. The current state of clinical investigation for vasculitis relies heavily upon determination of disease status solely by clinical presentation and investigator opinion. Thus, discovery and validation of more precise markers that quantifiably measure activity, predict disease course, and correlate with an important biological process, would be of great importance. Knowledge to be gained from this study could potentially be highly important. Discovery of effective biomarkers of vasculitis and assessment of long term disease course and complications by the collection of clinical and diagnostic imaging studies proposed could lead to better care and less toxic treatment regimens. Furthermore, insight into the pathophysiology of vasculitis could be gained and this might lead to better treatments and improved outcomes in terms of reduction of vascular and treatment related complications. Ideally, excellent biomarkers reflect a sophisticated understanding of the pathophysiology of a disease.]]>
VCRC Baseline Comorbidity FormVCRC LVV (GCA/TAK) Baseline Medical History FormVCRC LVV (GCA/TAK) Physical Exam FormVCRC Baseline Vasculitis Medication FormBirmingham Vasculitis Activity Score (BVAS)VCRC TAK Eligibility ChecklistVCRC Follow-up Comorbidity FormVCRC LVV (GCA/TAK) Follow-up Medical History FormVCRC LVV (GCA/TAK) Physical Exam FormVCRC Follow-up Vasculitis Medication FormVCRC Laboratory Results FormVCRC LVVID WorksheetVCRC Patient Global Assessment FormVCRC Vasculitis Damage Index (VDI)VCRC Angiogram Study Form - Aorta and BranchesVCRC Angiogram Study Form – Celiac/Mesenteric/RenalVCRC Angiogram Study Form - CerebralVCRC Angiogram Study Form - CoronaryVCRC Angiogram Study Form - Left Lower ExtremityVCRC Angiogram Study Form - Left Upper ExtremityVCRC Angiogram Study Form - PulmonaryVCRC Angiogram Study Form - Right Lower ExtremityVCRC Angiogram Study Form - Right Upper ExtremityVCRC Change of Information FormVCRC Demographics FormVCRC Hospitalization FormVCRC Pregnancy FormVCRC Protocol TerminationSF-36 Health SurveyVCRC Tobacco, Alcohol and Drug FormInclusion Criteria: An adaptation of the American College of Rheumatology (ACR) criteria will be used for the diagnosis of TAK. At the time of inclusion, criterion #6, listed below, must be met (arteriogram abnormalities compatible with TAK, including conventional dye angiography or MR angiography or CT angiography), in addition to at least one of the other criteria listed below (#1 through #5). The criteria will have an additional degree of rigor in that arteriographic abnormalities will be essential for inclusion. Angiographic demonstration of features of TAK was not a requirement of the original criteria. Adapted American College of Rheumatology (ACR) criteria: Age at disease onset ≤50 years Claudication of extremities Decreased brachial artery pulse (one or both arteries) Blood pressure difference of >10 mm Hg between the arms Bruit over subclavian arteries or aorta Arteriogram abnormalities compatible with TAK (includes conventional dye angiography or MR angiography or CT angiography) Exclusion Criteria: Arteriographic lesions that could be entirely due to atherosclerosis Fibromuscular dysplasia Cogan's syndrome Bechet's disease Sarcoidosis Kawasaki's disease Giant cell arteritis (large vessel vasculitis and >50 years old) Syphilis or other infectious forms of large vessel vasculitis Inability of participants (or their guardians in the case of children) to give informed consent and to sign the consent form ]]>
This study is a project of the Vasculitis Clinical Research Consortium (VCRC), which is a consortium of investigators in several major North American vasculitis centers (Boston University, Brigham and Women's Hospital, Cleveland Clinic, Johns Hopkins, Mayo Clinic, Mount Sinai Hospital Toronto, St. Joseph's Healthcare Hamilton, University of Pennsylvania, University of Pittsburgh, and University of Utah. The VCRC is funded through the National Institutes of Health as a Rare Diseases Clinical Research Network with the purpose of promoting research in vasculitis. This study was opened to enrollment on April 17, 2006.]]>