Effect of Systemic Cooling in Vasospasms - Full Text View

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

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, 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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

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

Responsible Party:	University Hospital, Basel, Switzerland ( Selim Orguel, MD )
Study ID Numbers:	007-KRK-2004-001
First Received:	December 7, 2006
Last Updated:	September 25, 2008
ClinicalTrials.gov Identifier:	NCT00409123
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

Additional relevant MeSH terms:

Pathologic Processes

Disease

Syndrome

ClinicalTrials.gov processed this record on October 22, 2008

Sponsored by:	University Hospital, Basel, Switzerland
Information provided by:	University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:	NCT00409123