NCT05160610

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,720

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 16, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 16, 2021

Completed
16 days until next milestone

Study Start

First participant enrolled

January 1, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

February 17, 2023

Status Verified

January 1, 2023

Enrollment Period

1.2 years

First QC Date

November 16, 2021

Last Update Submit

February 16, 2023

Conditions

Thrombolysis Rate

Keywords

Acute ischemic strokeElectronic monitoringIntravenous thrombolysis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • Thrombolysis rate within 3 hours

    Up to 3 hours

  • Excellent neurological outcomes

    At 90 days

  • Favorable neurological outcomes

    At 90 days

  • modified Rankin Scale score

    At 90 days

  • All-cause death rate

    At 90 days

  • +3 more secondary outcomes

Other Outcomes (3)

  • the proportion of acute ischemic stroke patients with Door-to-Needle Time≤60min

    Up to 4.5 hours

  • Door-to-needle time

    Up to 4.5 hours

  • Onset-to-needle time

    Up to 24 hours

Study Arms (2)

Intervention group

EXPERIMENTAL

receiving multilevel intervention, electronic monitoring and stroke registry participation

Behavioral: Multilevel intervention

Control group

NO INTERVENTION

receiving routine care , electronic monitoring and stroke registry participation

Interventions

Multilevel interventionBEHAVIORAL

Multilevel intervention based on AACTT theory

Intervention group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Contraindication for intravenous thrombolysis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Zexin Chen

    Ethics committee the second affiliated hospital, school of medicine, Zhejiang University, China

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Min Lou, PhD

CONTACT

13958007213loumingxc@vip.sina.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2021

First Posted

December 16, 2021

Study Start

January 1, 2022

Primary Completion

March 31, 2023

Study Completion

June 30, 2023

Last Updated

February 17, 2023

Record last verified: 2023-01

Locations

CN(1)