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

NACompletedINTERVENTIONAL
Enrollment

174

Participants

Timeline

Start Date

January 1, 2017

Primary Completion Date

February 28, 2019

Study Completion Date

February 28, 2019

Conditions
Raynaud DiseaseRaynaud PhenomenonHand and Arm Vibration SyndromeDiabetes MellitusParkinson DiseaseGlaucomaAutonomic NeuropathyAutonomic 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."

Trial Locations (1)

2730

Department of Clinical Physiology and Nuclear Medicine, Herlev Hospital, Herlev

All Listed Sponsors
lead

Herlev Hospital

OTHER

NCT03094910 - Investigation of the Rewarming og the Fingers After Cooling and the Autonomic Nervous System in Raynaud's Phenomenon | Biotech Hunter | Biotech Hunter