Vasospastic SyndromeNCT00409123
Effect of Systemic Cooling in Vasospasms
An observational study of Vasospastic Syndrome, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 19 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vasospastic Syndrome
- How many people
- 28 participants
- Where
- 1 siteSwitzerland
- Study dates
- Sep 2004to Jun 2006
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: vasospastic women
Who may be able to join
- women
- luteal phase or contraceptives
- 19-35 years
Who cannot join
- somatic diseases
- psychiatric diseases
- BMI > 25
- BMI < 18
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Systemic Cooling in Vasospasms (Kühleffekte Beim Vasospastischen Syndrom)
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.
Read the 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.
- Conditions
- Vasospastic Syndrome
- Keywords
- vasospastic women, controls, core cooling, core warming, external cooling, external warming, LDF, choroidal blood flow, temperature, vasospastic subjects, normal subjects
What is being measured
The primary outcome is the main question the study is designed to answer.
LDF blood flow
Measured: repeated after each challenge
LDF velocity
Measured: repeated after each challenge
finger skin temperature
Measured: repeated after each challenge
core body temperature
Measured: repeated after each challenge
corneal temperature
Measured: repeated after each challenge
Secondary outcomes (2)
subjective sleepiness
Measured: repeated after each challenge
subjective ratings of thermal comfort
Measured: repeated after each challenge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2006 (estimated)
- Study startSep 2004
- Primary completionMay 2006
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vasospastic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Investigators
- Selim Orguel, MD, Study director, Unversity Eye Clinic Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00409123
- Sponsor's protocol ID
- 007-KRK-2004-001
- Status last verified
- Sep 2008
- First submitted
- 7 Dec 2006
- Last updated
- 26 Sep 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Systemic Cooling in Vasospasms (Kühleffekte Beim Vasospastischen Syndrom)
- ClinicalTrials.gov ID
- NCT00409123
- Acronym / sponsor ID
- 007-KRK-2004-001
- Conditions
- Vasospastic Syndrome
- Keywords
- vasospastic women, controls, core cooling, core warming, external cooling, external warming, LDF, choroidal blood flow
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- Sep 2004
- Primary completion
- May 2006 (actual)
- Study completion
- Jun 2006 (actual)
- First posted
- 8 Dec 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- vasospastic women
Key inclusion criteria (3 listed)
- women
- luteal phase or contraceptives
- 19-35 years
Key exclusion criteria (4 listed)
- somatic diseases
- psychiatric diseases
- BMI > 25
- BMI < 18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
LDF blood flow
Time frame: repeated after each challenge
LDF velocity
Time frame: repeated after each challenge
finger skin temperature
Time frame: repeated after each challenge
core body temperature
Time frame: repeated after each challenge
corneal temperature
Time frame: repeated after each challenge
2 secondary outcomes
subjective sleepiness
Time frame: repeated after each challenge
subjective ratings of thermal comfort
Time frame: repeated after each challenge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Selim Orguel, MD study director
Unversity Eye Clinic Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vasospastic Syndrome, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LDF blood flow (time frame: repeated after each challenge). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2008.