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CompletedNCT00281034Updated Apr 12, 2012

OASIS STUDY Outcome Assessment Using SF-36 v2 in Stroke Patient Study(OASIS STUDY)

An observational study in Stroke, sponsored by Kyorin Pharmaceutical Co.,Ltd. Completed at 1 site in Japan. Per ClinicalTrials.gov, last updated 2012-04-12.

Sponsored by Kyorin Pharmaceutical Co.,Ltd · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
2,069
Sex
All
01

Study summary

  1. To survey the health-related quality of life using the SF-36v2 score of patients with chronic brain infarction in Japan
  2. Chronic brain infarction in Japan is better than EU/USA
Read the detailed description

Period:2005-2007

Observation Time:baseline, 8week, 24week

matters investigated:

  1. QOL determination using SF-36 v2
  2. Age, sex, brain infarction type, stroke severity (modified Rankin scale), side of stroke, complication, smoking, alcohol, dizziness-vertigo-presyncope-light headedness, combination medicine, subjective symptoms, psychic symptoms, rehabilitation, recurrence, evaluation of depression (Japan-Stroke Scale (JSS)-D)
02

Conditions studied

  • Stroke

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Keywords

  • brain infarction
  • SF-36
  • HRQOL
  • Japan
  • Post-stroke syndrome
03

In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.

This study's enrollment of 2,069 is above the median of 160 across 1,692 observational studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Kyorin Pharmaceutical Co.,Ltd is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Univercity, Main hospital, general Hospital,0pen

Inclusion criteria

  1. Patients whose last attack occurred more than 1 month ago
  2. Outpatients (including hospitalization for rehabilitation)
  3. Japanese nationality
  4. Patients who consented to participate in this study
  5. Group I: Patients with dizziness, vertigo, presyncope, and light-headedness which are likely due to secondary chronic cerebral circulation impairment associated with sequelae of brain infarction, and patients for whom KETAS (IBUDILAST) was prescribed Group II: Patients without dizziness, vertigo, presyncope, and light-headedness which are likely due to chronic cerebral circulation impairment associated with sequelae of brain infarction

Exclusion criteria

Exclusion Criteria:

  1. Patients who cannot read, understand and fill in the questionnaire by themselves
  2. Patients who idle their time away
  3. Patients who are hospitalized
  4. Patients who are undergoing treatment for dizziness, vertigo, presyncope, light-headedness which are likely due to chronic cerebral circulation impairment associated with sequelae of brain infarction
  5. Patients whose dizziness, vertigo, presyncope, and light-headedness is definitely or likely caused by Meniere disease, vestibular neuronitis, benign paroxysmal positional vertigo, otitis media, or epilepsy6. Patients whom the investigator judges are not suitable to participate in the study
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
2,069 participants (actual)

Groups and cohorts

  • OASIS Study Group
06

What researchers measure

Primary outcomes

  1. score of SF-36

    Time frame: 0, 8 week, 24 week

07

Study locations

1 site
  • Federation of National Public Service Personnel Mutual Aid Associations Tachikawa Hospital
    Tachikawa-City, Tokyo 190-8531, Japan
08

References and documents

Publications

  • Shinohara Y; OASIS Study Group. Factors affecting health-related quality of life assessed with the SF-36v2 health survey in outpatients with chronic-stage ischemic stroke in Japan--cross-sectional analysis of the OASIS study. Cerebrovasc Dis. 2010;29(4):361-71. doi: 10.1159/000281834. Epub 2010 Feb 9. PubMed 20145390 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 12, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00281034
Lead sponsor
Kyorin Pharmaceutical Co.,Ltd
Responsible party
Yukito Shinohara (Federation of National Public Service Personnel Mutual Aid Associations Tachikawa Hospital, Kyorin Pharmaceutical Co.,Ltd) — Principal investigator
First posted
Jan 24, 2006
Start date
Sep 2005
Completion
Jul 2007
Last update
Apr 12, 2012

Study contacts

Yukito Shinohara, MD
study chair · Federation of National Public Service Personnel Mutual Aid Associations Tachikawa Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2012. You cannot join it, but the record below documents what was studied.

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