Effect of Systemic Cooling in Vasospasms
This study has been completed.
Sponsor:
University Hospital, Basel, Switzerland
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
| Tracking Information | |||||
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| First Received Date ICMJE | December 7, 2006 | ||||
| Last Updated Date | September 25, 2008 | ||||
| Start Date ICMJE | September 2004 | ||||
| Primary Completion Date | May 2006 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
LDF blood flow, LDF velocity, finger skin temperature, core body temperature, corneal temperature | ||||
| Change History | Complete list of historical versions of study NCT00409123 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
subjective sleepiness, subjective ratings of thermal comfort, | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effect of Systemic Cooling in Vasospasms | ||||
| Official Title ICMJE | Effect of Systemic Cooling in Vasospasms (Kühleffekte Beim Vasospastischen Syndrom) | ||||
| 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. |
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| 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | vasospastic women |
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| Condition ICMJE | Vasospastic Syndrome | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 28 | ||||
| Completion Date | June 2006 | ||||
| Primary Completion Date | May 2006 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 19 Years to 35 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Switzerland | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00409123 | ||||
| Other Study ID Numbers ICMJE | 007-KRK-2004-001 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Selim Orguel, MD, University Hospital, Basel, Switzerland | ||||
| Study Sponsor ICMJE | University Hospital, Basel, Switzerland | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University Hospital, Basel, Switzerland | ||||
| Verification Date | September 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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