NCT00409123

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2004

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2006

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 7, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 8, 2006

Completed
Last Updated

September 26, 2008

Status Verified

September 1, 2008

Enrollment Period

1.7 years

First QC Date

December 7, 2006

Last Update Submit

September 25, 2008

Conditions

Vasospastic Syndrome

Keywords

vasospastic womencontrolscore coolingcore warmingexternal coolingexternal warmingLDFchoroidal blood flowtemperaturevasospastic subjectsnormal subjects

Outcome Measures

Primary Outcomes (5)

  • LDF blood flow

    repeated after each challenge

  • LDF velocity

    repeated after each challenge

  • finger skin temperature

    repeated after each challenge

  • core body temperature

    repeated after each challenge

  • corneal temperature

    repeated after each challenge

Secondary Outcomes (2)

  • subjective sleepiness

    repeated after each challenge

  • subjective ratings of thermal comfort

    repeated after each challenge

Eligibility Criteria

Age19 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

vasospastic women

You may qualify if:

  • women
  • luteal phase or contraceptives
  • years

You may not qualify if:

  • somatic diseases
  • psychiatric diseases
  • BMI \> 25
  • BMI \< 18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Eye Clinic

Basel, Basel, 4056, Switzerland

Location

Study Officials

  • Selim Orguel, MD

    Unversity Eye Clinic Basel

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 7, 2006

First Posted

December 8, 2006

Study Start

September 1, 2004

Primary Completion

May 1, 2006

Study Completion

June 1, 2006

Last Updated

September 26, 2008

Record last verified: 2008-09

Locations

CH(1)