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.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 174
- 试验地点
- 1
- 主要终点
- Heart rate variability (HRV)
研究概览
简要总结
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.
详细描述
Raynaud's phenomenon:
Raynaud's phenomenon is defined by vasospasms occurring in the fingers, toes, nose, ears or tongue lasting for minutes to hours. The attacks of vasospasms are provoked by cold exposure or stressful emotions and present themselves as well demarcated pallor of the skin and may include desensitization of the discolored area. Then cyanosis and eventually redness occur due to post ischemic hyperemia, which also can give rise to paresthesia and pain.
The phenomenon can be divided into a primary, idiopathic form - Raynaud's disease - that represents up to 90 % of all cases of Raynaud's phenomenon, is seen primarily in patients less than 40 years, and is usually considered benign. While the secondary form is often associated with rheumatic disorders such as scleroderma, it is also seen connected to other diseases, including vibration injury, external compression (e.g. a neck rib), medication, and vascular disorders such as atherosclerosis.
The prevalence of Raynaud's phenomenon varies among studies according to diagnostic criteria and geography as the climate affects the occurrence: In Northern Europe 15-20 % of the population is affected while the prevalence is 2-5 % in Southern Europe. An increased prevalence of migraine, chest pain, including Prinzmetal's angina, has been demonstrated in patients with Raynaud's disease. A study with 3,442 participants found an association between Raynaud's disease and cardiovascular disease, including ischemic heart disease, intermittent claudication, heart failure and cerebrovascular disease. Furthermore, an increased mortality has been found in Caucasian patients with Raynaud's disease. Consequently, Raynaud's disease might be a sign of or a precursor to cardiovascular disease.
Documentation of Raynaud's phenomenon:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Attacks of demarcated pallor of the skin of the fingers provoked by exposure to cold
排除标准
- •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
研究组 & 干预措施
123I-MIBG
Only the group of participants with primary Raynaud's phenomenon (Raynaud's disease) is also scheduled for this intervention, the 123I-MIBG.
干预措施: Examination of vibration perception threshold in fingertips (Diagnostic Test)
123I-MIBG
Only the group of participants with primary Raynaud's phenomenon (Raynaud's disease) is also scheduled for this intervention, the 123I-MIBG.
干预措施: Ewing's tests (Diagnostic Test)
123I-MIBG
Only the group of participants with primary Raynaud's phenomenon (Raynaud's disease) is also scheduled for this intervention, the 123I-MIBG.
干预措施: Tilt table test (Diagnostic Test)
123I-MIBG
Only the group of participants with primary Raynaud's phenomenon (Raynaud's disease) is also scheduled for this intervention, the 123I-MIBG.
干预措施: Thermography (Diagnostic Test)
All participants
Examination of vibration perception threshold in fingertips, thermography, Ewing's test, tilt table test, blood samples.
干预措施: Tilt table test (Diagnostic Test)
All participants
Examination of vibration perception threshold in fingertips, thermography, Ewing's test, tilt table test, blood samples.
干预措施: Thermography (Diagnostic Test)
123I-MIBG
Only the group of participants with primary Raynaud's phenomenon (Raynaud's disease) is also scheduled for this intervention, the 123I-MIBG.
干预措施: Blood samples (Diagnostic Test)
All participants
Examination of vibration perception threshold in fingertips, thermography, Ewing's test, tilt table test, blood samples.
干预措施: Examination of vibration perception threshold in fingertips (Diagnostic Test)
All participants
Examination of vibration perception threshold in fingertips, thermography, Ewing's test, tilt table test, blood samples.
干预措施: Ewing's tests (Diagnostic Test)
All participants
Examination of vibration perception threshold in fingertips, thermography, Ewing's test, tilt table test, blood samples.
干预措施: Blood samples (Diagnostic Test)
123I-MIBG
Only the group of participants with primary Raynaud's phenomenon (Raynaud's disease) is also scheduled for this intervention, the 123I-MIBG.
干预措施: 123I-MIBG (Diagnostic Test)
结局指标
主要结局
Heart rate variability (HRV)
时间窗: Participant is examined once for 1,5 hours.
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.
Thermography of the hands after cooling - a composite evaluation of the rewarming ability
时间窗: Participant is examined once for a maximum of 1 hour.
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.
次要结局
未报告次要终点
研究者
Lotte Lindberg
Principal investigator
Herlev Hospital