Stroke, Acute
Conditions
Brief summary
This study aims to observe the safety and effectiveness of intravenous thrombolysis for acute ischemic stroke in real-world clinical practice.
Detailed description
IVTIS is a prospective, real-world registry lasting for 22 years. A total of 3000 patients with intravenous thrombolysis will be enrolled。
Interventions
Intravenous thrombolysis using thrombolytic drugs such as ateplase and teneplase.
Sponsors
Zhengzhou Yuan
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Inclusion criteria
* The patient was diagnosed with acute ischemic stroke and received intravenous thrombolysis.
Exclusion criteria
* No additional
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Symptom-to-thrombolysis time | 24 hours | Time from onset of symptoms to thrombolytic therapy. |
| Excellent functional outcome | 90±7 days | Proportion of subjects with mRS 0-1 at 90±7 days. |
| 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 |
| Door-to-Needle Time | 24 hours | Time from the arrival of stroke patient in emergency to initiation of thrombolysis therapy. |
Countries
China
Contacts
Primary ContactZhengzhou Yuan, MD
Outcome results
None listed