Registration of Intravenous Thrombolysis for Acute Ischemic Stroke in Southwestern China（IVTIS）
Study Details
Study Description
Brief Summary
This study aims to observe the safety and effectiveness of intravenous thrombolysis for acute ischemic stroke in real-world clinical practice.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
IVTIS is a prospective, real-world registry lasting for 22 years. A total of 3000 patients with intravenous thrombolysis will be enrolled。
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Acute ischemic stroke treated with intravenous thrombolysis All of acute ischemic stroke patients who treated with intravenous thrombolysis. |
Drug: intravenous thrombolysis
Intravenous thrombolysis using thrombolytic drugs such as ateplase and teneplase.
|
Outcome Measures
Primary Outcome Measures
- modified Rankin Scale (mRS) score [90±7 days]
Ordinal distribution of mRS at 90±7 days; modified Rankin scale (range, 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death)
Secondary Outcome Measures
- Excellent functional outcome [90±7 days]
Proportion of subjects with mRS 0-1 at 90±7 days.
- Good functional outcome [90±7 days]
Proportion of subjects with mRS 0-2 at 90±7 days.
- mRS 0-3 [90±7 days]
Proportion of subjects with mRS 0-3 at 90±7 days.
- Change of National Institutes of Health Stroke Scale (NIHSS) [24 hours]
Change of National Institutes of Health Stroke Scale (NIHSS, a scale between 0 and 42 on which higher scores indicate more severe neurologic deficits) from baseline to 24 hours.
- Change of National Institutes of Health Stroke Scale (NIHSS) [7 days]
Change of National Institutes of Health Stroke Scale (NIHSS, a scale between 0 and 42 on which higher scores indicate more severe neurologic deficits) from baseline to 7 days.
- Symptom-to-thrombolysis time [24 hours]
Time from onset of symptoms to thrombolytic therapy.
- Door-to-Needle Time [24 hours]
Time from the arrival of stroke patient in emergency to initiation of thrombolysis therapy.
- Incidence of clinically significant intracranial hemorrhage [36 hours]
Incidence of sICH (Heidelberg criteria) measured at 36 hours
- Incidence of any intracranial hemorrhage [36 hours]
Incidence of any intracranial hemorrhage (Heidelberg criteria) measured at 36 hours
- All-cause mortality [90±7 days]
All-cause mortality at 90±7 days
- Complications related to intravenous thrombolysis [up to 7 days]
Complications related to intravenous thrombolysis during hospitalization
Eligibility Criteria
Criteria
Inclusion Criteria:
- The patient was diagnosed with acute ischemic stroke and received intravenous thrombolysis.
Exclusion Criteria:
- No additional exclusion criteria.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Affiliated Hospital of Southwest Medical University | Luzhou | China | 646000 |
Sponsors and Collaborators
- Zhengzhou Yuan
Investigators
- Study Chair: Zhengzhou Yuan, Department of Neurology, Affiliated Hospital of Southwest Medical University, Lu
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SWMU-2023-12