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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yukito Shinohara, Kyorin Pharmaceutical Co.,Ltd
ClinicalTrials.gov Identifier:
NCT00281034
First received: January 23, 2006
Last updated: April 10, 2012
Last verified: April 2012
  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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Outcome Assessment Using SF-36 v2 in Stroke Patient Study(OASIS Study)

Resource links provided by NLM:


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

Primary Outcome Measures:
  • score of SF-36 [ Time Frame: 0, 8 week, 24 week ] [ Designated as safety issue: Yes ]

Enrollment: 2069
Study Start Date: September 2005
Study Completion Date: July 2007
Groups/Cohorts
OASIS Study Group

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Japan
Federation of National Public Service Personnel Mutual Aid Associations Tachikawa Hospital
Tachikawa-City, Tokyo, Japan, 190-8531
Sponsors and Collaborators
Kyorin Pharmaceutical Co.,Ltd
Investigators
Study Chair: Yukito Shinohara, MD Federation of National Public Service Personnel Mutual Aid Associations Tachikawa Hospital
  More Information

No publications provided by Kyorin Pharmaceutical Co.,Ltd

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Yukito Shinohara, Federation of National Public Service Personnel Mutual Aid Associations Tachikawa Hospital, Kyorin Pharmaceutical Co.,Ltd
ClinicalTrials.gov Identifier: NCT00281034     History of Changes
Other Study ID Numbers: OASIS-2005, oasis-2007
Study First Received: January 23, 2006
Last Updated: April 10, 2012
Health Authority: Japan: Institutional Review Board

Keywords provided by Kyorin Pharmaceutical Co.,Ltd:
brain infarction
SF-36
HRQOL
Japan
Post-stroke syndrome

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on July 24, 2014