Patients with acute ischemic stroke and stationary condition in the convalescent phase Circulatory System Acute ischemic stroke
Conditions
Interventions
For the primary objective of the study, an estimated sample size of 58 study patients in each group is based on the effective size with an a = 0.05, a power of 80%, an improvement of 1.5 in NIHSS scor
Sponsors
Chang Gung Memorial Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Suffer from acute ischemic stroke within 14 ± 7 days 2. Evidence of brain ischemia on nuclear medicine examination 3. NIHSS score between 8 and 21 4. Already on standard medical therapy based upon stroke guideline, e.g., antiplatelet, antihypertensive, and statin.
Exclusion criteria
Exclusion criteria: 1. Age less than 45 years old or more than 80 years old 2. Patients received t-PA and anticoagulation 3. Non-middle cerebral artery territory stroke or hemorrhagic stroke 4. Pregnant women 5. Patients with active infectious disease or autoimmune disorder 6. Myocardial infarction (MI) within 3 months 7. Severe aortic stenosis or mitral stenosis 8. Congestive heart failure, New York Heart Association functional class IV 9. Malignancy or other severe disease with life span less than one year 10. Chronic kidney disease with CCr<20ml/min and end stage renal disease 11. Join other clinical trials 12. Patients cannot receive regular follow-up 13. Other brain disease (tumor, degenerative disease, infective disease)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Events of all-cause mortality and recurrent ischemic stroke are recorded at 90 days and 1 year | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Post-therapy 90-day combined endpoint of recurrent stroke or death 2. Post-therapy disability is evaluated with modified Rankin Scale score and Barthel Index; WAIS-III and CASI National Institutes of Health Stroke Scale (NIHSS) within 1, 3, and 30 days (±14 days) and 90 days (±14 days): 3. Post-therapy brain reperfusion status is measured by using brain Magnetic resonance imaging [Arterial Spin Labeling (ASL) and Dynamic Contrast Enhancement] at 24-72 hours and 90 days (±14 days) 4. Post-therapy brain perfusion defect evaluation is measured using radionuclear medicine image [brain Tc-99m scan] 24-72 hours and 90 days (±14 days) 5. Any adverse events are recorded within 5 years post-therapy | — |
Countries
Taiwan
Contacts
Public ContactHon-Kan Yip
Outcome results
None listed