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

NCT02615964 | Completed

• 1 other identifier: 2014-1128
• Study Type: observational
• Target: 5
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Raynaud's Disease

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Nova Flow Procedure RADIATION

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.

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients presenting to UIC rheumatology clinic with Raynaud's disorder and scleroderma will be asked to participate.

Sponsors & Collaborators

• University of Illinois at Chicago: lead

MeSH Terms

Conditions

Raynaud Disease

Condition Hierarchy (Ancestors)

Livedoid Vasculopathy; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Nadera J Sweiss, MD

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: July 8, 2015
• First Posted: November 26, 2015
• Study Start: May 1, 2015
• Primary Completion: June 1, 2015
• Study Completion: December 1, 2015
• Last Updated: May 12, 2016

Record last verified: 2016-05