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

This study is currently recruiting participants.
Verified March 2017 by Lotte Lindberg, Herlev Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT03094910
First Posted: March 29, 2017
Last Update Posted: March 29, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Lotte Lindberg, Herlev Hospital
  Purpose

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.


Condition Intervention
Raynaud Disease Raynaud Phenomenon Hand and Arm Vibration Syndrome Diabetes Mellitus Parkinson Disease Glaucoma Autonomic Neuropathy Autonomic Imbalance Diagnostic Test: Examination of vibration perception threshold in fingertips Diagnostic Test: Ewing's tests Diagnostic Test: Tilt table test Diagnostic Test: Thermography Diagnostic Test: 123I-MIBG Diagnostic Test: Blood samples

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Lotte Lindberg, Herlev Hospital:

Primary Outcome Measures:
  • Thermography of the hands after cooling - a composite evaluation of the rewarming ability [ Time Frame: 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.


  • Heart rate variability (HRV) [ Time Frame: 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.


Estimated Enrollment: 160
Actual Study Start Date: January 1, 2017
Estimated Study Completion Date: December 31, 2018
Estimated Primary Completion Date: December 31, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
123I-MIBG
Only the group of participants with primary Raynaud's phenomenon (Raynaud's disease) is also scheduled for this intervention, the 123I-MIBG.
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.

All participants
Examination of vibration perception threshold in fingertips, thermography, Ewing's test, tilt table test, blood samples.
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: 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.


  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Criteria depend on the specific group of participants. Criteria described below are applicable to the group of participants with Raynaud's syndrome

Inclusion Criteria:

- Attacks of demarcated a pallor of the skin of the fingers provoked by exposure to cold

Exclusion Criteria:

  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03094910


Contacts
Contact: Lotte Lindberg, MD 0045 3868 6563 lotte.lindberg.01@regionh.dk

Locations
Denmark
Department of Clinical Physiology and Nuclear Medicine, Herlev Hospital Recruiting
Herlev, Capital Region, Denmark, 2730
Contact: Lotte Lindberg, MD    0045 3868 6563    lotte.lindberg.01@regionh.dk   
Contact: Lars T Jensen, DMSc    0045 3868 1237    lars.thorbjoern.jensen@regionh.dk   
Sponsors and Collaborators
Herlev Hospital
Investigators
Study Director: Lars T Jensen, DMSc Department of Clinical Physiology, Herlev Hospital
  More Information

Responsible Party: Lotte Lindberg, Principal investigator, Herlev Hospital
ClinicalTrials.gov Identifier: NCT03094910     History of Changes
Other Study ID Numbers: HGH-2016-111
H-16035842 ( Other Identifier: Research Ethics Committee of the Capital Region )
First Submitted: March 8, 2017
First Posted: March 29, 2017
Last Update Posted: March 29, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Lotte Lindberg, Herlev Hospital:
Raynaud Phenomenon
Hand and Arm Vibration Syndrome
Autonomic Imbalance
Thermography

Additional relevant MeSH terms:
Diabetes Mellitus
Parkinson Disease
Glaucoma
Raynaud Disease
Nervous System Diseases
Hand-Arm Vibration Syndrome
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Ocular Hypertension
Eye Diseases
Peripheral Vascular Diseases
Vascular Diseases
Cardiovascular Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Occupational Diseases