Endovascular Treatment Key Technique and Emergency Work Flow Improvement of Acute Ischemic Stroke (ANGEL-ACT): Phase Two

Last updated: November 10, 2019
Sponsor: Beijing Tiantan Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Occlusions

Treatment

N/A

Clinical Study ID

NCT04151589
2016YFC1301501-2
  • Ages > 18
  • All Genders

Study Summary

The study is the second phase of Endovascular Treatment Key Technique and Emergency Work Flow Improvement of Acute Ischemic Stroke (ANGEL-ACT).

During the first phase of the ANGEL-ACT (NCT03370939, a prospective multi-center registry study), problems and difficulties in the emergency work flow of acute ischemic stroke care in China have been identified, such as inadequate pre-hospital notification, delay of in-hospital diagnosis and treatment, difficulty in treatment consent, lack of professional training of endovascular treatment,etc., especially in the delay of in-hospital diagnosis and treatment.

ANGEL-ACT II is a cluster randomized, parallel controlled study. The aim of this study was to evaluate the effectiveness of multi-modal medical quality improvement measures on the delay of hospital-level emergency work flow of acute ischemic stroke management as well as its impact on patient prognosis. The interventional measures include emergency work flow management app on smartphone, specialized training, assessment of quality improvement outcomes and feedback on a regular basis.

Eligibility Criteria

Inclusion

Investigational Sites Inclusion Criteria:

  • Participated in the ANGEL-ACT registry study

  • Secondary or tertiary hospitals

  • Available of emergency department and neurology ward for stroke patients

  • Must have 24 hours × 7 days emergency department for stroke

  • Capable of rt-PA thrombolysis and endovascular treatment Investigational Sites Exclusion Criteria

  • Endovascular treatment volume ＜ 20 per year

  • Unwillingness to participate ANGEL-ACT II and follow the protocol

  • Currently participating other stroke treatment improving program/project or similarclinical studies Participant Inclusion Criteria

  • Age ≥ 18 years old

  • Admitted from emergency or outpatient department;

  • Acue ischemic stroke with large artery occlusion

  • Within 24 hours after the onset, and eligible for endovascular treatment.

  • The patient or legal representative give written informed consent

Exclusion

Participant Exclusion Criteria:

  • Unsuitable for this study investigators' discretion

  • Progressive stroke or in-hospital stroke

Study Design

Total Participants: 664
Study Start date:
August 22, 2019
Estimated Completion Date:
June 30, 2021

Study Description

This is a prospective, multi-centre, cluster randomized, open label, parallel controlled study that enrolled patients with acute ischemic stroke who underwent endovascular treatment in about 34 hospitals in China. The ratio Interventional arm control arm is 1:1, which means 17 hospitals and 332 participants in each arm.

Connect with a study center

  • Beijing Tiantan Hospital

    Beijing, Beijing 100010
    China

    Active - Recruiting

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