Effect of Systemic Cooling in Vasospasms

Vasospastic Syndrome Clinical Trial

Official title:

Effect of Systemic Cooling in Vasospasms (Kühleffekte Beim Vasospastischen Syndrom)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00409123
• Other study ID #: 007-KRK-2004-001
• Status: Completed
• Phase: N/A
• First received: December 7, 2006
• Last updated: September 25, 2008
• Start date: September 2004
• Est. completion date: June 2006

Study information

• Verified date: September 2008
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: June 2006
• Est. primary completion date: May 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 19 Years to 35 Years

Eligibility

Inclusion Criteria:

• women

• luteal phase or contraceptives

• 19-35 years

Exclusion Criteria:

• somatic diseases

• psychiatric diseases

• BMI > 25

• BMI < 18

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Vasospastic Syndrome

Locations

Country	Name	City	State
Switzerland	University Eye Clinic	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	LDF blood flow		repeated after each challenge	No
Primary	LDF velocity		repeated after each challenge	No
Primary	finger skin temperature		repeated after each challenge	No
Primary	core body temperature		repeated after each challenge	No
Primary	corneal temperature		repeated after each challenge	No
Secondary	subjective sleepiness		repeated after each challenge	No
Secondary	subjective ratings of thermal comfort		repeated after each challenge	No