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Improving Thrombolysis Implementation Based on Electronic Monitoring in Acute Ischemic Stroke (ITEM)

Primary Purpose

Thrombolysis Rate

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Multilevel intervention
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thrombolysis Rate focused on measuring Acute ischemic stroke, Electronic monitoring, Intravenous thrombolysis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients presented with clinical signs of acute ischemic stroke within 4.5 hours of stroke onset
  2. Patient's age is >18 years

Exclusion Criteria:

Contraindication for intravenous thrombolysis

Sites / Locations

  • Second Affiliated Hospital, School of Medicine, Zhejiang UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Control group

Arm Description

receiving multilevel intervention, electronic monitoring and stroke registry participation

receiving routine care , electronic monitoring and stroke registry participation

Outcomes

Primary Outcome Measures

Thrombolysis rate within 4.5 hours
The proportion of acute ischemic stroke patients within 4.5 hours of onset

Secondary Outcome Measures

Thrombolysis rate within 3 hours
The proportion of acute ischemic stroke patients within 3 hours of onset
Excellent neurological outcomes
Score of 0 to 1 on the modified Rankin Scale, on which scores range from 0 (no neurologic deficit) to 6 (death)
Favorable neurological outcomes
Score of 0 to 1 on the modified Rankin Scale, on which scores range from 0 (no neurologic deficit) to 6 (death)
modified Rankin Scale score
The distribution of modified Rankin Scale score at 90 days, on which scores range from 0 (no neurologic deficit) to 6 (death)
All-cause death rate
All-cause death rate at 90 days
Hemorrhagic transformation
the presence of hemorrhagic transformation is defined according to European Cooperative Acute Stroke Study (ECASS) II trial
Symptomatic intracranial hemorrhage
Intracranial hemorrhage at 24 hours associated with an increase of ≥4 points of NIHSS score from baseline, according to European Cooperative Acute Stroke Study (ECASS) II trial
Door-to-image time
The time between hospital arrival and the initiation of image

Full Information

First Posted
November 16, 2021
Last Updated
February 16, 2023
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
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1. Study Identification

Unique Protocol Identification Number
NCT05160610
Brief Title
Improving Thrombolysis Implementation Based on Electronic Monitoring in Acute Ischemic Stroke (ITEM)
Official Title
Improving Thrombolysis Implementation Based on Electronic Monitoring in Acute Ischemic Stroke (ITEM): a Cluster Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
March 31, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A cluster randomized controlled trial will be conducted. Hospitals in Zhejiang Province, China, will be randomized into two arms (1:1): an intervention arm and a control arm. Hospitals in the intervention arm will receive a multilevel intervention based on the AACTT theory, whereas hospitals in the control arm will receive no intervention and maintain routine care. All the hospitals will receive electronic monitoring. Hospitals with no stroke center or with <20 cases received thrombolysis per year will be excluded from the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thrombolysis Rate
Keywords
Acute ischemic stroke, Electronic monitoring, Intravenous thrombolysis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
2720 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
receiving multilevel intervention, electronic monitoring and stroke registry participation
Arm Title
Control group
Arm Type
No Intervention
Arm Description
receiving routine care , electronic monitoring and stroke registry participation
Intervention Type
Behavioral
Intervention Name(s)
Multilevel intervention
Intervention Description
Multilevel intervention based on AACTT theory
Primary Outcome Measure Information:
Title
Thrombolysis rate within 4.5 hours
Description
The proportion of acute ischemic stroke patients within 4.5 hours of onset
Time Frame
Up to 4.5 hours
Secondary Outcome Measure Information:
Title
Thrombolysis rate within 3 hours
Description
The proportion of acute ischemic stroke patients within 3 hours of onset
Time Frame
Up to 3 hours
Title
Excellent neurological outcomes
Description
Score of 0 to 1 on the modified Rankin Scale, on which scores range from 0 (no neurologic deficit) to 6 (death)
Time Frame
At 90 days
Title
Favorable neurological outcomes
Description
Score of 0 to 1 on the modified Rankin Scale, on which scores range from 0 (no neurologic deficit) to 6 (death)
Time Frame
At 90 days
Title
modified Rankin Scale score
Description
The distribution of modified Rankin Scale score at 90 days, on which scores range from 0 (no neurologic deficit) to 6 (death)
Time Frame
At 90 days
Title
All-cause death rate
Description
All-cause death rate at 90 days
Time Frame
At 90 days
Title
Hemorrhagic transformation
Description
the presence of hemorrhagic transformation is defined according to European Cooperative Acute Stroke Study (ECASS) II trial
Time Frame
At 7 days
Title
Symptomatic intracranial hemorrhage
Description
Intracranial hemorrhage at 24 hours associated with an increase of ≥4 points of NIHSS score from baseline, according to European Cooperative Acute Stroke Study (ECASS) II trial
Time Frame
At 7 days
Title
Door-to-image time
Description
The time between hospital arrival and the initiation of image
Time Frame
Up to 4.5 hours
Other Pre-specified Outcome Measures:
Title
the proportion of acute ischemic stroke patients with Door-to-Needle Time≤60min
Description
Difference between intervention arm and control arm in the percentage of patients receiving thrombolysis within 60 minutes of stroke onset
Time Frame
Up to 4.5 hours
Title
Door-to-needle time
Description
The time between hospital arrival and the initiation of IVT
Time Frame
Up to 4.5 hours
Title
Onset-to-needle time
Description
The time between the symptom onset and the initiation of IVT
Time Frame
Up to 24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients presented with clinical signs of acute ischemic stroke within 4.5 hours of stroke onset Patient's age is >18 years Exclusion Criteria: Contraindication for intravenous thrombolysis
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Min Lou, PhD
Phone
13958007213
Email
loumingxc@vip.sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zexin Chen
Organizational Affiliation
Ethics committee the second affiliated hospital, school of medicine, Zhejiang University, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Second Affiliated Hospital, School of Medicine, Zhejiang University
City
Hangzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Min Lou, PhD
Phone
8657187784811
Email
loumingxc@vip.sina.com
First Name & Middle Initial & Last Name & Degree
Min Lou, PhD

12. IPD Sharing Statement

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Improving Thrombolysis Implementation Based on Electronic Monitoring in Acute Ischemic Stroke (ITEM)

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