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

Work Flow Improvement in Pre-procedural Management of Acute Ischemic Stroke With Endovascular Treatment: a Multi-centre, Cluster Randomised, Open Label, Parallel Controlled Study

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.

Study Overview

• Status: Unknown
• Conditions: Intracranial Artery Occlusion With Infarction (Disorder)
• Intervention / Treatment: Behavioral: ANGEL Intervention Package and Toolbox

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 664
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100010
      • Recruiting
      • Beijing TianTan Hospital
      • Contact: Zhongrong Miao, PhD,MD; Phone Number: 13601243293; Email: 13601243293@163.com

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

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 similar clinical 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

Participant Exclusion Criteria:

• Unsuitable for this study investigators' discretion
• Progressive stroke or in-hospital stroke

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Interventional Site; The process below will be allocated in Interventional Sites: 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.; Drafting intervention approaches based on the assessment results of all interventional sites. These approaches are executable, reproducible, and measurable.; Emergency work flow management APP would be installed on smartphones of designated personnel at each interventional sites.; Both intervention approaches and APP would be incorporated with original work flow at each interventional site.; Training sessions would be held in interventional sites or online every 3 month once the patient enrolment begin.; Outcome data would be analysed and dispatched every 3 month for each interventional sites.	Behavioral: 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.
NO_INTERVENTION: Control Site; The control site would not undergo any emergency work flow modification for acute ischemic stroke patients who eligible for endovascular treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of reaching the standard arrival-to-groin Puncture time	The percentage of reaching the guideline recommended time target for acute ischemic stroke patients who eligible for endovascular treatment.	From the time of arrival at the emergency department until the time of successful groin puncture, assessed up to 12 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time from arrival to groin puncture	Minutes	From the time of arrival at the emergency department until the time of successful groin puncture, assessed up to 12 hours
Time from arrival to imaging	Minutes	From the time of arrival at the emergency department until the time of brain imaging, assessed up to 12 hours
Time from imaging to groin puncture	Minutes	From the time of brain imaging until the time of successful groin puncture, assessed up to 12 hours
Time from groin puncture to recanalization	Minutes	From the time of successful groin puncture until the time of the recanalization of the occluded artery, assessed up to 4 hours
Time from arrival to recanalization	Minutes	From the time of arrival at the emergency department until the time of the recanalization of the occluded artery, assessed up to 48 hours
Time from symptom onset to recanalization	Minutes	From the time of symptom onset until the time of of the recanalization of the occluded artery, assessed up to 48 hours
Recanalization rate immediately after the procedure	modified thrombolysis in cerebral infarction (mTICI) 2b-3	Immediately after the procedure
Recanalization rate 24 hours after the procedure	Recanalization was defined as a thrombolysis in myocardial infarction (TIMI ) score of 2- 3.	24 hours after the procedure
Modified Rankin Scale independence rate within 90 days after the procedure	The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. (Score Description: 0---No symptoms at all. 1---No significant disability despite symptoms; able to carry out all usual duties and activities. 2---Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance. 3---Moderate disability; requiring some help, but able to walk without assistance. 4--- Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance. 5---Severe disability; bedridden, incontinent and requiring constant nursing care and attention. 6---Dead. In clinical practice, mRS ≤ 2 means good outcome. Modified Rankin Scale independence rate refers to the percentage of participants with mRS less than 3 after treatment.	90 days after enrolment
EQ-5D-3L 90 days after the procedure	The EQ-5D-3L essentially consists of two pages: the EQ-5D descriptive system and the EQ-5D visual analogue scale (EQ VAS). The EQ-5D-3L descriptive system comprises the following five dimensions, each describing a different aspect of health: MOBILITY, SELF-CARE, USUAL ACTIVITIES, PAIN / DISCOMFORT and ANXIETY / DEPRESSION. Each dimension has three levels: no problems, some problems, extreme problems (labelled 1-3). The respondent is asked to indicate his / her health state by checking the box against the most appropriate statement in each of the five dimensions. The EQ VAS records the respondent's self-rated health on a vertical VAS where the endpoints are labelled 'The best health you can imagine'( score as 100) and 'The worst health you can imagine' (score as 0). This information can be used as a quantitative measure of health outcome as judged by the individual respondents.	90 days after the procedure
Rate of symptomatic intracerebral hemorrhage within 24 hours after the procedure		24 hours within the procedure ended
Rate of complications related to the procedure		24 hours after the procedure
Rate of all cause mortality within 90 days after the procedure		90 days after enrolment

Collaborators and Investigators

• Sponsor: Beijing Tiantan Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 22, 2019
• Primary Completion (ANTICIPATED): December 31, 2020
• Study Completion (ANTICIPATED): June 30, 2021

Study Registration Dates

• First Submitted: November 1, 2019
• First Submitted That Met QC Criteria: November 1, 2019
• First Posted (ACTUAL): November 5, 2019

Study Record Updates

• Last Update Posted (ACTUAL): November 13, 2019
• Last Update Submitted That Met QC Criteria: November 10, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Infarction; Ischemic Stroke
• Other Study ID Numbers: 2016YFC1301501-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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