Coronary VasospasmNCT00350129
Effect of Glucose on Ocular Blood Flow
An observational study of Coronary Vasospasm, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
The primary objective is to assess the effect of glucose on retinal vascular diameter in otherwise healthy vasospastic subjects compared to non-vasospastic controls. The secondary objective is to compare the effect of glucose also on choroidal blood flow in otherwise healthy vasospastic subjects with non-vasospastic… Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronary Vasospasm
- How many people
- 24 participants
- Where
- 1 siteSwitzerland
- Study dates
- Dec 2002to Feb 2003
- 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 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: healthy vasospastic subjects, healthy non-vasospastic subjects
Who may be able to join
- No history of the following problems: ocular or systemic disease; chronic or current systemic or topical medication; or of drug or alcohol abuse
- normal blood pressure (100-140 / 60-90 mmhg)
- best corrected visual acuity above 20/25 in both eyes
- no pathological findings upon a slit-lamp examination and indirect fundoscopy
- ametropia within -3 to +3 diopters of spherical equivalent
- less than 1 diopter astigmatism
Show all 9Show fewer
- IOP < 20 mmHg in both eyes
- Subjects will be classified as vasospastic if they relate a clear history of frequent cold hands (answering yes to the questions: "do you have always cold hands, even during summer time?" and "do other people tell you that you have cold hands?") and as normals if they deny such a history
- Vasospastic propensity will also be assessed by capillaroscopy
Who cannot join
- Subjects describing "sometimes cold hands"
- if the test substance cannot be ingested
- not obtainable ocular blood flow measurements
- abnormally high levels of glucose at any point in time
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Basel, Eye Clinic
Basel, Canton of Basel-City, 4031
About this study
Official title: Influence of Plasma Glucose Levels on Retinal Vascular Diameter and Choroidal Blood Flow in Vasospastic Subjects
The primary objective is to assess the effect of glucose on retinal vascular diameter in otherwise healthy vasospastic subjects compared to non-vasospastic controls.
The secondary objective is to compare the effect of glucose also on choroidal blood flow in otherwise healthy vasospastic subjects with non-vasospastic controls.
Read the detailed description
It is known that a glucose load can induce an increase in ocular blood flow. Acute hyperglycemia increases retinal vessel diameters in animals and humans. The purpose of this study is to compare the effect of glucose on the ocular blood flow in vasospastics and nonvasospastics. Body core temperature depends on basal metabolism. Peripheral vasoconstriction is a physiological way to preserve core temperature of the body. The etiology of primary vasospastic syndrome is unknown and potentially represents simply a reaction to a defective metabolism. Based on this hypothesis, vasospastics are expected to show a different vascular reaction to glucose.
On both study days, after an overnight fast, the subjects will be seated for 30 minutes in the Lab and local tropicamide will be applied for pupil dilatation. After stabilisation of blood pressure Retinal vessel diameter and choroidal blood flow will be assessed. Baseline blood glucose levels will be measured. Afterwards study substance (75 gram of Glucose or Aspartate) will be applied in 3 dl of water. One and a half hour later, the vascular measurements will be repeated. Ath the end of hemodynamic assessments, blood sugar level will be measured again.
- Conditions
- Coronary Vasospasm
- Keywords
- glucose, vasospasm, RVA, LDF, vasospastic subjects, non-vasospastic subjects
- Medical subject headings
- Coronary Vasospasm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | healthy vasospastic subjects | |
| 2 | healthy non-vasospastic subjects |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2006 (estimated)
- Study startDec 2002
- Primary completionFeb 2003
- Study completionFeb 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary VasospasmStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- 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-control
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Investigators
- Selim Orgül, MD, Study director, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00350129
- Sponsor's protocol ID
- 005-ZAC-2004-002
- Status last verified
- Mar 2024
- First submitted
- 7 Jul 2006
- Last updated
- 19 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Plasma Glucose Levels on Retinal Vascular Diameter and Choroidal Blood Flow in Vasospastic Subjects
- ClinicalTrials.gov ID
- NCT00350129
- Acronym / sponsor ID
- 005-ZAC-2004-002
- Conditions
- Coronary Vasospasm
- Keywords
- glucose, vasospasm, RVA, LDF, vasospastic subjects, non-vasospastic subjects
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- Dec 2002
- Primary completion
- Feb 2003 (actual)
- Study completion
- Feb 2003 (actual)
- First posted
- 10 Jul 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.
The primary objective is to assess the effect of glucose on retinal vascular diameter in otherwise healthy vasospastic subjects compared to non-vasospastic controls.
The secondary objective is to compare the effect of glucose also on choroidal blood flow in otherwise healthy vasospastic subjects with non-vasospastic controls.
Detailed description
It is known that a glucose load can induce an increase in ocular blood flow. Acute hyperglycemia increases retinal vessel diameters in animals and humans. The purpose of this study is to compare the effect of glucose on the ocular blood flow in vasospastics and nonvasospastics. Body core temperature depends on basal metabolism. Peripheral vasoconstriction is a physiological way to preserve core temperature of the body. The etiology of primary vasospastic syndrome is unknown and potentially represents simply a reaction to a defective metabolism. Based on this hypothesis, vasospastics are expected to show a different vascular reaction to glucose.
On both study days, after an overnight fast, the subjects will be seated for 30 minutes in the Lab and local tropicamide will be applied for pupil dilatation. After stabilisation of blood pressure Retinal vessel diameter and choroidal blood flow will be assessed. Baseline blood glucose levels will be measured. Afterwards study substance (75 gram of Glucose or Aspartate) will be applied in 3 dl of water. One and a half hour later, the vascular measurements will be repeated. Ath the end of hemodynamic assessments, blood sugar level will be measured again.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –healthy vasospastic subjects |
| 2 | – | –healthy non-vasospastic subjects |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- healthy vasospastic subjects, healthy non-vasospastic subjects
Key inclusion criteria (9 listed)
- No history of the following problems: ocular or systemic disease; chronic or current systemic or topical medication; or of drug or alcohol abuse
- normal blood pressure (100-140 / 60-90 mmhg)
- best corrected visual acuity above 20/25 in both eyes
- no pathological findings upon a slit-lamp examination and indirect fundoscopy
- ametropia within -3 to +3 diopters of spherical equivalent
Key exclusion criteria (4 listed)
- Subjects describing "sometimes cold hands"
- if the test substance cannot be ingested
- not obtainable ocular blood flow measurements
- abnormally high levels of glucose at any point in time
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
Not reported in the source record.
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 19 Mar 2024.
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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 Orgül, MD study director
University Hospital, Basel, Switzerland
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 Coronary Vasospasm, 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 9 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 19 Mar 2024. 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.
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 19 Mar 2024.