Clinical Trial: Nova Cold Hands Raynaud's Disorder, a Disease Which Results in Decreased Blood Flow to the Hands and Feet.

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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 Resu

Brief Summary: 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.

Detailed Summary:

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.


Sponsor: University of Illinois at Chicago

Current Primary Outcome: The measurement of blood flow [ Time Frame: Up to one year ]

There will be two visits in the study. Each of those visits will take about one hour.

  • First visit will consist of: NOVA flow procedure, Medical history, Digital photographic assessments, Nail bed capillaroscopy and questionnaires.
  • Second visit will occur one month after the first visit and consist of: Follow up for any adverse events due to the study. Review any changes with the hands that received the NOVA procedure. Complete any follow up questionnaires needed for the study.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: University of Illinois at Chicago

Dates:
Date Received: July 8, 2015
Date Started: May 2015
Date Completion:
Last Updated: May 10, 2016
Last Verified: May 2016