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Effect of Systemic Cooling in Vasospasms

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00409123
First Posted: December 8, 2006
Last Update Posted: September 26, 2008
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. Read our disclaimer for details.
Information provided by:
University Hospital, Basel, Switzerland
  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 ]
  • LDF velocity [ Time Frame: repeated after each challenge ]
  • finger skin temperature [ Time Frame: repeated after each challenge ]
  • core body temperature [ Time Frame: repeated after each challenge ]
  • corneal temperature [ Time Frame: repeated after each challenge ]

Secondary Outcome Measures:
  • subjective sleepiness [ Time Frame: repeated after each challenge ]
  • subjective ratings of thermal comfort [ Time Frame: repeated after each challenge ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 35 Years   (Adult)
Sexes 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
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): 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

Responsible Party: Selim Orguel, MD, University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT00409123     History of Changes
Other Study ID Numbers: 007-KRK-2004-001
First Submitted: December 7, 2006
First Posted: December 8, 2006
Last Update Posted: September 26, 2008
Last Verified: September 2008

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