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Completed

NCT Number: NCT00281034

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

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

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Key information

Conditions

Stroke Brain Diseases Brain Infarction Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Infarction Ischemia Necrosis Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Federation of National Public Service Personnel Mutual Aid Associations Tachikawa Hospital

Tachikawa, Tokyo, 190-8531, Japan

About this study

Period:2005-2007

Observation Time:baseline, 8week, 24week

matters investigated:

  • QOL determination using SF-36 v2
  • 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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients whose last attack occurred more than 1 month ago
  • Outpatients (including hospitalization for rehabilitation)
  • Japanese nationality
  • Patients who consented to participate in this study
  • 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

  • Patients who cannot read, understand and fill in the questionnaire by themselves
  • Patients who idle their time away
  • Patients who are hospitalized
  • 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
  • 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

Treatment and study plan

Primary outcomes

  1. score of SF-36

    Time frame: 0, 8 week, 24 week

Sponsors and collaborators

Lead sponsor

Kyorin Pharmaceutical Co.,Ltd

Industry

Registry information

Official study title

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

Important dates

Study start
2005
Study completion
2007
First posted
Jan 24, 2006
Registry last updated
Apr 12, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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