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

Intracranial Artery Occlusion With Infarction (Disorder) Clinical Trial

— ANGEL-ACT II  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04151589
• Other study ID #: 2016YFC1301501-2
• Status: Recruiting
• Phase: N/A
• Start date: August 22, 2019
• Est. completion date: June 30, 2021

Study information

• Verified date: November 2019
• Source: Beijing Tiantan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 664
• Est. completion date: June 30, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infarction
• Intracranial Artery Occlusion With Infarction (Disorder)

Intervention

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.

Locations

Country	Name	City	State
China	Beijing Tiantan Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tiantan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Recanalization rate immediately after the procedure	modified thrombolysis in cerebral infarction (mTICI) 2b-3	Immediately after the procedure
Secondary	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
Secondary	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
Secondary	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
Secondary	Rate of symptomatic intracerebral hemorrhage within 24 hours after the procedure		24 hours within the procedure ended
Secondary	Rate of complications related to the procedure		24 hours after the procedure
Secondary	Rate of all cause mortality within 90 days after the procedure		90 days after enrolment