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

NCT ID: NCT02615964

Last Updated: 2016-05-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 5 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2015-12-31

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 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.

Conditions

Raynaud's Disease

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

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.

Intervention Type: RADIATION

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Illinois at Chicago

OTHER

Sponsor Role: lead

Responsible Party

Nadera J. Sweiss

Associate Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nadera J Sweiss, MD

Role: PRINCIPAL_INVESTIGATOR

University of Illinois at Chicago

Other Identifiers

2014-1128

Identifier Type: -

Identifier Source: org_study_id