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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00281034
• Other study ID #: OASIS-2005
• Secondary ID: oasis-2007
• Status: Completed
• Phase: N/A
• First received: January 23, 2006
• Last updated: April 10, 2012
• Start date: September 2005
• Est. completion date: July 2007

Study information

• Verified date: April 2012
• Source: Kyorin Pharmaceutical Co.,Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Observational

Clinical Trial 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

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2069
• Est. completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Stroke

Locations

Country	Name	City	State
Japan	Federation of National Public Service Personnel Mutual Aid Associations Tachikawa Hospital	Tachikawa-City	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Kyorin Pharmaceutical Co.,Ltd

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	score of SF-36		0, 8 week, 24 week	Yes