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

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.

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02615964
• Other study ID #: 2014-1128
• Status: Enrolling by invitation
• Phase: N/A
• First received: July 8, 2015
• Last updated: November 23, 2015
• Start date: May 2015
• Est. completion date: December 2015

Study information

• Verified date: November 2015
• Source: University of Illinois at Chicago
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 5
• Est. completion date: December 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Inclusionary criteria for this study will be patients with a diagnosis of Raynaud's disease and scleroderma (per ACR criteria for the diagnosis for systemic sclerosis) and age between 18-85.

Exclusion Criteria:

• Exclusion criteria for Raynaud's patients will include history of botox injection to the hands within 6 months, non-English speaking patients and those unable to understand informed consent, and the presence of confounding medical conditions preventing the patient from full participation.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Raynaud Disease
• Raynaud's Disease

Intervention

Radiation:
• Nova Flow Procedure
Evaluation of the diagnosis, and stratification of the severity of Raynaud's disorder in patients with scleroderma based on clinical and imaging data will allow creation of more precise diagnostic criteria as well as disease classification which may guide treatment practices. The study results will likely have no immediate benefit to the patients participating in the study, however may have a future impact diagnosis, stratification and ultimately treatment of patients with Raynaud's disorder. In addition, data collected in this study may provide insight into disease process and leading to future research endeavors.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Illinois at Chicago

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The measurement of blood flow	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.	Up to one year	No