Raynaud's DiseaseNCT02615964
Nova Cold Hands Raynaud's Disorder, a Disease Which Results in Decreased Blood Flow to the Hands and Feet.
An observational study of Raynaud's Disease, run by University of Illinois Chicago.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Raynaud's Disease
- What is being tested?
- Nova Flow Procedure
- Type of treatment
- Surgery or procedure
- How many people
- 5 participants
- Where
- No sites listed yet
- Study dates
- May 2015to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients presenting to UIC rheumatology clinic with Raynaud's disorder and scleroderma will be asked to participate.
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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.
Read the 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:
- 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
- Being tested
- Nova Flow Procedure
- Medical subject headings
- Raynaud Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nova Flow ProcedureRadiation
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2015 (estimated)
- Study startMay 2015
- Primary completionJun 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Raynaud's DiseaseStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nadera J. Sweiss, University of Illinois Chicago
- Investigators
- Nadera J Sweiss, MD, Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02615964
- Sponsor's protocol ID
- 2014-1128
- Status last verified
- May 2016
- First submitted
- 8 Jul 2015
- Last updated
- 12 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02615964
- Acronym / sponsor ID
- 2014-1128
- Conditions
- Raynaud's Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Jun 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 26 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting to UIC rheumatology clinic with Raynaud's disorder and scleroderma will be asked to participate.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nova Flow ProcedureEvaluation 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. | Radiation | – |
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nadera J Sweiss, MD principal investigator
University of Illinois Chicago
Questions about this trial
What is this clinical trial studying?
An observational study of Raynaud's Disease, run by University of Illinois Chicago.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The measurement of blood flow (time frame: Up to one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2016.