Investigation of the Rewarming og the Fingers After Cooling and the Autonomic Nervous System in Raynaud's Phenomenon
RaynAUT
RaynAUT - Thermography and the Autonomic Nervous System in Raynaud's Phenomenon - Investigation of the Autonomic Nervous System in Patients With Raynaud's Phenomenon, Glaucoma, and Autonomic Neuropathy.
2 other identifiers
interventional
174
1 country
1
Brief Summary
Patients with Raynaud's disease have an increased tendency of chest pain and migraine, and studies indicate that the disease might be associated with increased cardiovascular morbidity and mortality. Furthermore, a certain hyperactivity of the sympathetic nervous system has been demonstrated in these patients. Hyperactivity of the sympathetic nervous system is known to cause decreasing heart function, regardless of the underlying disease. The cardiac autonomic nervous function and thermographic parameters will be assessed in patients with primary and secondary Raynaud's phenomenon and glaucoma as well as in patients diagnosed with autonomic dysfunction such as diabetics and patients with Parkinson's disease in order to compare the function of the cardiac autonomic nervous system and the peripheral response to cold exposure. Potentially, this will lead to a better understanding of the cardiac autonomic nervous function in Raynaud's phenomenon. Moreover, it might give rise to a new perception of the condition and its association to cardiovascular disease. At the Department of Clinical Physiology, the current method of detecting Raynaud's phenomenon is time-consuming and unpleasant to the patient due to cooling for several minutes. Another aim of the PhD study is to implement infrared thermography as a gentler and possibly more sensitive method to replace the currently applied method. The project will also include an epidemiological study based on data obtained from the National Patient Registry, among others. Raynaud's phenomenon will be paired with diagnostic codes of conditions such as diabetes mellitus, Parkinson's disease, glaucoma, and cardiovascular disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2017
CompletedFirst Submitted
Initial submission to the registry
March 8, 2017
CompletedFirst Posted
Study publicly available on registry
March 29, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2019
CompletedFebruary 28, 2019
February 1, 2019
2.2 years
March 8, 2017
February 27, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Thermography of the hands after cooling - a composite evaluation of the rewarming ability
Determination of which variables are able to distinguish the participants with Raynaud's phenomenon from the healthy participants. Temperature (degrees celsius), time (minutes), degrees/min, acceleration of temperature change (degrees/min\^2), recovery index (percent). All measurements will be evaluated in terms of ability to diagnose Raynaud's phenomenon. Finally, the most prominent variables are aggregated to determine whether or not the participant has Raynaud's phenomenon or not.
Participant is examined once for a maximum of 1 hour.
Heart rate variability (HRV)
Determination of HRV from participants with Raynaud's phenomenon, with diagnosed autonomic neuropathy, and healthy participants. All measurements will be aggregated to determine whether HRV differs among the different groups of participants.
Participant is examined once for 1,5 hours.
Study Arms (2)
123I-MIBG
OTHEROnly the group of participants with primary Raynaud's phenomenon (Raynaud's disease) is also scheduled for this intervention, the 123I-MIBG.
All participants
OTHERExamination of vibration perception threshold in fingertips, thermography, Ewing's test, tilt table test, blood samples.
Interventions
Vibration perception threshold is examined for 7 different frequences. All fingers are examined except for the thumbs.
A battery of tests invented to diagnose the cardiac autonomic neuropathy in diabetics. Heart rate and blood pressure are measured during Valsalva maneuver, deep breathing, active standing and prolonged handgrip.
Blood pressure and heart rate are measured continuously while the participant is brought to a 60 degree position and held there for 15 minutes.
An infrared thermographic camera is applied to record temperature of the fingers of the participant before and after cooling in 10 degree water for 1 min.
123I-MIBG is injected into a vein, and an early and a late scan is performed. Regions Of Interest are selected for the heart and mediastinum, and the ratio as well as well as the Washout Rate can be determined. MIBG is a noradrenaline analogue and the examination is performed to visualize a potential imbalance of the autonomic nervous system of the heart.
The blood samples will be assayed for hemoglobin, long-term blood sugar, C-reactive protein, sodium, potassium, magnesium, albumin, TSH, vitamin B and D, and ionized calcium. Patients with suspected Raynaud's disease will be tested for anti-nuclear antibodies (ANA) to screen for underlying rheumatic illness. Blood samples will also be drawn during tilt table testing and assayed for plasma catecholamines.
Eligibility Criteria
You may qualify if:
- \- Attacks of demarcated pallor of the skin of the fingers provoked by exposure to cold
You may not qualify if:
- Positive Anti-Nuclear Antibodies
- Connective tissue disease
- Current smoker
- Current treatment with beta blocker
- Other predisposing factors for developing Raynaud's phenomenon
- Pacemaker
- Cardiac arrhythmia
- Pregnancy
- Diabetes mellitus
- Parkinson's disease
- Glaucoma
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Herlev Hospitallead
Study Sites (1)
Department of Clinical Physiology and Nuclear Medicine, Herlev Hospital
Herlev, Capital Region, 2730, Denmark
Related Publications (1)
Lindberg L, Kristensen B, Thomsen JF, Eldrup E, Jensen LT. Characteristic Features of Infrared Thermographic Imaging in Primary Raynaud's Phenomenon. Diagnostics (Basel). 2021 Mar 20;11(3):558. doi: 10.3390/diagnostics11030558.
PMID: 33804657DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Lars T Jensen, DMSc
Department of Clinical Physiology, Herlev Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
March 8, 2017
First Posted
March 29, 2017
Study Start
January 1, 2017
Primary Completion
February 28, 2019
Study Completion
February 28, 2019
Last Updated
February 28, 2019
Record last verified: 2019-02
Data Sharing
- IPD Sharing
- Will not share