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OASIS STUDY( Outcome Assessment Using SF-36 v2 in Stroke Patient Study(OASIS STUDY)
This study has been completed.
Sponsored by: Kyorin Pharmaceutical Co.,Ltd
Information provided by: Kyorin Pharmaceutical Co.,Ltd
ClinicalTrials.gov Identifier: NCT00281034
  Purpose
  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

Condition
Stroke

U.S. FDA Resources
Study Type: Observational
Study Design: Cohort, Prospective
Official Title: Outcome Assessment Using SF-36 v2 in Stroke Patient Study(OASIS Study)

Further study details as provided by Kyorin Pharmaceutical Co.,Ltd:

Biospecimen Retention:   None Retained

Biospecimen Description:

Enrollment: 2069
Study Start Date: September 2005
Study Completion Date: July 2007
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)
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Univercity, Main hospital, general Hospital,0pen

Criteria

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:

  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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00281034

Locations
Japan, Tokyo
Kyosai Tachikawa Hospital
Tachikawa-City, Tokyo, Japan, 190-8531
Sponsors and Collaborators
Kyorin Pharmaceutical Co.,Ltd
Investigators
Study Chair: Yukito Shinohara, MD KYOSAI TACHIKAWA HOSPITAL
Study Chair: Yukito Shinohara, MD KYOSAI TACHIKAWA HOSPITAL
  More Information

Study ID Numbers: OASIS-2005, oasis-2007
Study First Received: January 23, 2006
Last Updated: November 1, 2007
ClinicalTrials.gov Identifier: NCT00281034  
Health Authority: Japan: Institutional Review Board

Keywords provided by Kyorin Pharmaceutical Co.,Ltd:
brain infarction
SF-36
QOL
Japan
5

Study placed in the following topic categories:
Cerebral Infarction
Stroke
Vascular Diseases
Central Nervous System Diseases
Brain Infarction
Brain Diseases
Infarction
Cerebrovascular Disorders

Additional relevant MeSH terms:
Nervous System Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 15, 2009