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
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, see Learn About Clinical Studies.

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 September 18, 2014