Investigation of the Rewarming og the Fingers After Cooling and the Autonomic Nervous System in Raynaud's Phenomenon

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.

Conditions

• Raynaud Disease
• Raynaud Phenomenon
• Hand and Arm Vibration Syndrome
• Diabetes Mellitus
• Parkinson Disease
• Glaucoma
• Autonomic Neuropathy
• Autonomic Imbalance

Interventions

DIAGNOSTIC_TEST

Examination of vibration perception threshold in fingertips

Vibration perception threshold is examined for 7 different frequences. All fingers are examined except for the thumbs.

DIAGNOSTIC_TEST

Ewing's tests

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.

DIAGNOSTIC_TEST

Tilt table test

Blood pressure and heart rate are measured continuously while the participant is brought to a 60 degree position and held there for 15 minutes.

DIAGNOSTIC_TEST

Thermography

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.

DIAGNOSTIC_TEST

123I-MIBG

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.

DIAGNOSTIC_TEST

Blood samples

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.

Sponsors & Collaborators

• Herlev Hospital

  lead OTHER

Principal Investigators

• Lars T Jensen, DMSc · Department of Clinical Physiology, Herlev Hospital

Study Design

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2017-01-01

Primary Completion

2019-02-28

Completion

2019-02-28

Countries

• Denmark

Study Locations