Effect of Systemic Cooling in Vasospasms

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT00409123
First received: December 7, 2006
Last updated: September 25, 2008
Last verified: September 2008
  Purpose

This study tests whether women with Vasospastic Syndrome (VS) react more intensive than controls with distal vasomotions and choroidal blood flow changes to internal cooling/warming and external cooling/warming.


Condition
Vasospastic Syndrome

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Effect of Systemic Cooling in Vasospasms (Kühleffekte Beim Vasospastischen Syndrom)

Further study details as provided by University Hospital, Basel, Switzerland:

Primary Outcome Measures:
  • LDF blood flow [ Time Frame: repeated after each challenge ] [ Designated as safety issue: No ]
  • LDF velocity [ Time Frame: repeated after each challenge ] [ Designated as safety issue: No ]
  • finger skin temperature [ Time Frame: repeated after each challenge ] [ Designated as safety issue: No ]
  • core body temperature [ Time Frame: repeated after each challenge ] [ Designated as safety issue: No ]
  • corneal temperature [ Time Frame: repeated after each challenge ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • subjective sleepiness [ Time Frame: repeated after each challenge ] [ Designated as safety issue: No ]
  • subjective ratings of thermal comfort [ Time Frame: repeated after each challenge ] [ Designated as safety issue: No ]

Enrollment: 28
Study Start Date: September 2004
Study Completion Date: June 2006
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
Detailed Description:

Distal vasomotions and choroidal blood flow changes to internal cooling/warming and external cooling/warming was studied in VS and controls.Core cooling was induced by drinking of 250g ice/water mixture (4°C). Core warming was induced by drinking of 250g warm water (55°C). The study was controlled with respect to posture and room temperature.

  Eligibility

Ages Eligible for Study:   19 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

vasospastic women

Criteria

Inclusion Criteria:

  • women
  • luteal phase or contraceptives
  • 19-35 years

Exclusion Criteria:

  • somatic diseases
  • psychiatric diseases
  • BMI > 25
  • BMI < 18
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00409123

Locations
Switzerland
University Eye Clinic
Basel, Switzerland, 4056
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
Study Director: Selim Orguel, MD Unversity Eye Clinic Basel
  More Information

No publications provided

Responsible Party: Selim Orguel, MD, University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT00409123     History of Changes
Other Study ID Numbers: 007-KRK-2004-001
Study First Received: December 7, 2006
Last Updated: September 25, 2008
Health Authority: Switzerland: Swissmedic

Keywords provided by University Hospital, Basel, Switzerland:
vasospastic women
controls
core cooling
core warming
external cooling
external warming
LDF
choroidal blood flow
temperature
vasospastic subjects
normal subjects

ClinicalTrials.gov processed this record on April 17, 2014