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

Improving Thrombolysis Implementation Based on Electronic Monitoring in Acute Ischemic Stroke (ITEM): a Cluster Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Thrombolysis Rate
• Intervention / Treatment: Behavioral: Multilevel intervention

• Study Type: Interventional
• Enrollment (Anticipated): 2720
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Recruiting
      • Second Affiliated Hospital, School of Medicine, Zhejiang University
      • Contact: Min Lou, PhD; Phone Number: 8657187784811; Email: loumingxc@vip.sina.com
      • Principal Investigator: Min Lou, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; receiving multilevel intervention, electronic monitoring and stroke registry participation	Behavioral: Multilevel intervention; Multilevel intervention based on AACTT theory
No Intervention: Control group; receiving routine care , electronic monitoring and stroke registry participation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Thrombolysis rate within 4.5 hours	The proportion of acute ischemic stroke patients within 4.5 hours of onset	Up to 4.5 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	At 90 days
Thrombolysis rate within 3 hours	The proportion of acute ischemic stroke patients within 3 hours of onset	Up to 3 hours
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)	At 90 days
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)	At 90 days
All-cause death rate	All-cause death rate at 90 days	At 90 days
Hemorrhagic transformation	the presence of hemorrhagic transformation is defined according to European Cooperative Acute Stroke Study (ECASS) II trial	At 7 days
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	At 7 days
Door-to-image time	The time between hospital arrival and the initiation of image	Up to 4.5 hours

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Onset-to-needle time	The time between the symptom onset and the initiation of IVT	Up to 24 hours
the proportion of acute ischemic stroke patients with Door-to-Needle Time≤60min	Difference between intervention arm and control arm in the percentage of patients receiving thrombolysis within 60 minutes of stroke onset	Up to 4.5 hours
Door-to-needle time	The time between hospital arrival and the initiation of IVT	Up to 4.5 hours

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Investigators: Principal Investigator: Zexin Chen, Ethics committee the second affiliated hospital, school of medicine, Zhejiang University, China

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Anticipated): March 31, 2023
• Study Completion (Anticipated): June 30, 2023

Study Registration Dates

• First Submitted: November 16, 2021
• First Submitted That Met QC Criteria: December 6, 2021
• First Posted (Actual): December 16, 2021

Study Record Updates

• Last Update Posted (Actual): February 17, 2023
• Last Update Submitted That Met QC Criteria: February 16, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Acute ischemic stroke; Intravenous thrombolysis; Electronic monitoring
• 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: ITEM

Drug and device information, study documents

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