Raynaud's Disease Clinical Trial
Official title:
'Defining the Gold Standard in Diagnosis and Stratification of Raynaud's Disorder', Nova Cold Hands Raynaud's Disorder. Raynaud's Disease is a Vascular Disorder Which Results in Decreased Blood Flow to the Hands and Feet.
Patients presenting to UIC rheumatology clinic with Raynaud's disorder and scleroderma will be asked to participate. 10 hands of patients with both Raynaud's disorder and scleroderma will be studied. This research study is being done to better understand Raynaud's disease and to assess the role of blood flow measurement in diagnosing the disorder, specifically, through data collected by an MRI procedure called NOVA FLOW. NOVA is a blood flow measurement software system owned by the study's sponsor, VasSol, Inc.
The investigators propose to obtain volumetric flow data on 10 hands of patients with
Raynaud's disorder and scleroderma at UIC rheumatology clinic and compare these results with
previously established volumetric flow data for non-Raynaud's patients. Through this
analysis, the invstigators will be able to better understand and correlate subjective and
objective measures of both disease presentation and progression. Collection of cross
sectional data will allow us to better address the following questions Is it possible to
more precisely diagnose patients with Raynaud's disorder based on NOVA analysis as well as
clinical findings
Is it possible to stratify patients with Raynaud's disorder into categories which may allow:
i. Prediction of disease course and prognosis ii. Prediction of response to specific
treatment modalities (vasodilators vs anti-coagulation vs surgical or chemical denervation)
The investigators propose to collect measurements of disease severity as well as functional
assessment of patients Raynaud's and scleroderma in order to address the following questions
c. Does NOVA flow and volume data correlate with measures of Raynaud's and scleroderma
disease severity index d. Does NOVA flow and volume data correlate with OT assessment of
hand functionality.
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Observational Model: Case-Only, Time Perspective: Prospective
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