NCT00350129

Brief 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 controls.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2002

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2002

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2003

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

July 7, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 10, 2006

Completed
Last Updated

March 19, 2024

Status Verified

March 1, 2024

Enrollment Period

2 months

First QC Date

July 7, 2006

Last Update Submit

March 18, 2024

Conditions

Coronary Vasospasm

Keywords

glucosevasospasmRVALDFvasospastic subjectsnon-vasospastic subjects

Study Arms (2)

1

healthy vasospastic subjects

2

healthy non-vasospastic subjects

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

healthy vasospastic subjects, healthy non-vasospastic subjects

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Basel, Eye Clinic

Basel, Canton of Basel-City, 4031, Switzerland

Location

MeSH Terms

Conditions

Coronary Vasospasm

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Selim Orgül, MD

    University Hospital, Basel, Switzerland

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 7, 2006

First Posted

July 10, 2006

Study Start

December 1, 2002

Primary Completion

February 1, 2003

Study Completion

February 1, 2003

Last Updated

March 19, 2024

Record last verified: 2024-03

Locations

CH(1)