Stroke, Acute Ischemic Stroke
Conditions
Brief summary
The EXTEND-IVT Registry is a prospective, multicenter, observational cohort study designed to evaluate the effectiveness and safety of intravenous thrombolysis administered beyond 4.5 hours after last known well in patients with acute ischemic stroke (AIS) in routine clinical practice across China.
Detailed description
This prospective, multicenter, observational cohort registry enrolls adult patients (≥18 years) with acute ischemic stroke who receive intravenous thrombolysis more than 4.5 hours after last known well. Patient selection, imaging strategies, thrombolytic agent choice, dosing, and concomitant therapies are determined by treating physicians according to local clinical practice, without study-mandated intervention. The primary outcome is the proportion of patients achieving a modified Rankin Scale (mRS) score of 0-1 at 90 ± 14 days. This registry describes real-world patient characteristics, treatment patterns, and outcomes of extended time window intravenous thrombolysis, and explores factors associated with clinical outcomes to inform patient selection and future clinical practice.
Interventions
Not applicable as this is an observational study.
Sponsors
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 1\. Age ≥ 18 years * 2\. Clinical diagnosed of acute ischemic stroke * 3\. Time from last known well (LKW) to initiation of intravenous thrombolysis \> 4.5 hours (including wake-up stroke and unwitnessed stroke) * 4\. Received intravenous thrombolysis * 5\. Provided written informed consent
Exclusion criteria
* 1\. Any condition judged by the investigator to make the participant unsuitable for study participation or follow-up (e.g., psychiatric disorders, cognitive impairment, or emotional disturbances).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The modified Rankin Scale score (mRS) 0-1 | 90±14 days | The proportion of mRS score 0-1 or a return to baseline if the pre-stroke mRS score ≥2 at 90±14 days. The modified Rankin Scale is a 7-point ordinal scale ranging from 0 to 6, with higher scores indicating greater disability (0 = no symptoms; 6 = death). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Level of disability | 90±14 days | The shift analysis of the mRS scores at 90±14 days. The modified Rankin Scale is a 7-point ordinal scale ranging from 0 to 6, with higher scores indicating greater disability (0 = no symptoms; 6 = death). |
| The modified Rankin Scale score (mRS) 0-2 | 90±14 days | The proportion of mRS score 0-2 at 90±14 days |
| The modified Rankin Scale score (mRS) 0-3 | 90±14 days | The proportion of mRS score 0-3 at 90±14 days |
| Change in neurologic deficit (NIHSS score) at 24 hours | 24±12 hours | Change in neurologic deficit (NIHSS score) from baseline to 24±12 hours after intravenous thrombolysis. The National Institutes of Health Stroke Scale (NIHSS) ranges from 0 to 42, with higher scores indicating more severe neurologic deficit. |
| Change in neurologic deficit (NIHSS score) at 7 days or discharge | 7±1 days | Change in neurologic deficit (NIHSS score) from baseline to 7±1 days or at discharge, if earlier. The National Institutes of Health Stroke Scale (NIHSS) ranges from 0 to 42, with higher scores indicating more severe neurologic deficit. |
| The modified Rankin Scale score (mRS) 0-1 at 1 year | 1 year ± 60 days | The proportion of mRS score 0-1 at 1 year ± 60 days |
| Stroke recurrence within 90 days | 90±14 days | Stroke recurrence and time to recurrence within 90 days |
| Stroke recurrence within 1 year | 1 year ± 60 days | Stroke recurrence and time to recurrence within 1 year |
Countries
China
Contacts
CONTACTMingyi Bao
CONTACTXinguang Yang
PRINCIPAL_INVESTIGATORYamei Tang
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
PRINCIPAL_INVESTIGATORYong He
Liuyang Jili Hospital
Outcome results
None listed