Registration of Intravenous Thrombolysis for Acute Ischemic Stroke in Southwestern China（IVTIS） (IVTIS)

This study aims to observe the safety and effectiveness of intravenous thrombolysis for acute ischemic stroke in real-world clinical practice.

Study Overview

• Status: Recruiting
• Conditions: Stroke, Acute
• Intervention / Treatment: Drug: intravenous thrombolysis

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 Type: Observational
• Enrollment (Estimated): 3000

Contacts and Locations

• Study Contact: Name: Zhengzhou Yuan, MD; Phone Number: +868303165661; Email: coneuro@163.com

Study Locations

• China
  • Luzhou, China, 646000
    • Recruiting
    • Affiliated Hospital of Southwest Medical University
    • Contact: Zhengzhou Yuan; Phone Number: +868303165661

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Patients with acute ischemic stroke who received intravenous thrombolysis will be included in the study and no additional exclusion criteria have been set.

Description

Inclusion Criteria:

• The patient was diagnosed with acute ischemic stroke and received intravenous thrombolysis.

Exclusion Criteria:

• No additional exclusion criteria.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
modified Rankin Scale (mRS) score	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)	90±7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of any intracranial hemorrhage	Incidence of any intracranial hemorrhage (Heidelberg criteria) measured at 36 hours	36 hours
Incidence of clinically significant intracranial hemorrhage	Incidence of sICH (Heidelberg criteria) measured at 36 hours	36 hours
All-cause mortality	All-cause mortality at 90±7 days	90±7 days
Excellent functional outcome	Proportion of subjects with mRS 0-1 at 90±7 days.	90±7 days
Good functional outcome	Proportion of subjects with mRS 0-2 at 90±7 days.	90±7 days
mRS 0-3	Proportion of subjects with mRS 0-3 at 90±7 days.	90±7 days
Change of National Institutes of Health Stroke Scale (NIHSS)	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.	24 hours
Change of National Institutes of Health Stroke Scale (NIHSS)	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.	7 days
Complications related to intravenous thrombolysis	Complications related to intravenous thrombolysis during hospitalization	up to 7 days
Door-to-Needle Time	Time from the arrival of stroke patient in emergency to initiation of thrombolysis therapy.	24 hours
Symptom-to-thrombolysis time	Time from onset of symptoms to thrombolytic therapy.	24 hours

Collaborators and Investigators

• Sponsor: Zhengzhou Yuan
• Investigators: Study Chair: Zhengzhou Yuan, Department of Neurology, Affiliated Hospital of Southwest Medical University, Lu

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2023
• Primary Completion (Estimated): December 15, 2045
• Study Completion (Estimated): May 1, 2046

Study Registration Dates

• First Submitted: November 9, 2023
• First Submitted That Met QC Criteria: November 9, 2023
• First Posted (Actual): November 14, 2023

Study Record Updates

• Last Update Posted (Actual): November 28, 2023
• Last Update Submitted That Met QC Criteria: November 26, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke
• Other Study ID Numbers: SWMU-2023-12

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No