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

NCT ID: NCT04151589

Last Updated: 2019-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

664 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-22

Study Completion Date

2021-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Intracranial Artery Occlusion With Infarction (Disorder)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Interventional Site

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1. At each interventional sites, implementing full assessment of current emergency work flow of acute ischemic stroke patients who eligible for endovascular treatment. All interventional sites would undergo assessment in order to form a baseline.
2. Drafting intervention approaches based on the assessment results of all interventional sites. These approaches are executable, reproducible, and measurable.
3. Emergency work flow management APP would be installed on smartphones of designated personnel at each interventional sites.
4. Both intervention approaches and APP would be incorporated with original work flow at each interventional site.
5. Training sessions would be held in interventional sites or online every 3 month once the patient enrolment begin.
6. Outcome data would be analysed and dispatched every 3 month for each interventional sites.

Group Type EXPERIMENTAL

ANGEL Intervention Package and Toolbox

Intervention Type BEHAVIORAL

The interventional measures include emergency work flow management app on smartphone, specialized training, assessment of quality improvement outcomes and feedback on a regular basis, patient-centred management frame based lean six-sigma, and other specialised approach.

Control Site

The control site would not undergo any emergency work flow modification for acute ischemic stroke patients who eligible for endovascular treatment.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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ANGEL Intervention Package and Toolbox

The interventional measures include emergency work flow management app on smartphone, specialized training, assessment of quality improvement outcomes and feedback on a regular basis, patient-centred management frame based lean six-sigma, and other specialised approach.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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


* 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 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 similar clinical studies


* Unsuitable for this study investigators' discretion
* Progressive stroke or in-hospital stroke
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Tiantan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Zhongrong Miao

Director of Department of interventional neurology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Beijing Tiantan Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Zhongrong Miao, PhD,MD

Role: primary

13601243293

Other Identifiers

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2016YFC1301501-2

Identifier Type: -

Identifier Source: org_study_id

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