Effect of Systemic Cooling in Vasospasms | NCT00409123

Studies
Effect of Systemic Cooling in Vasospasms

NCT00409123

Sponsor

University Hospital, Basel, Switzerland

Status

Completed

Last Update Posted

Sep 26, 2008Estimated

Enrollment

28Actual

Phase

Not provided

Conditions

Vasospastic Syndrome

Interventions

Not provided

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2004

Primary Completion Date

May 2006Actual

Completion Date

Jun 2006Actual

First Submitted Date

Dec 7, 2006

First Submission Date that Met QC Criteria

Dec 7, 2006

First Posted Date

Dec 8, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 25, 2008

Last Update Posted Date

Sep 26, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

28Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
subjective sleepiness		repeated after each challenge
subjective ratings of thermal comfort		repeated after each challenge

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

women
luteal phase or contraceptives
19-35 years

Exclusion Criteria:

somatic diseases
psychiatric diseases
BMI > 25
BMI < 18

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

vasospastic women

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Selim Orguel, MD	Unversity Eye Clinic Basel	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Eye Clinic		Basel	Basel	4056	Switzerland