Clinical trial NCT04151589: Endovascular Treatment Key Technique and Emergency Work Flow Improvement of Acute Ischemic Stroke (ANGEL-ACT): Phase Two
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intracranial Artery Occlusion With Infarction (Disorder)
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2019-11-05
Enrollment: 664
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of reaching the standard arrival-to-groin Puncture time
timeFrame: From the time of arrival at the emergency department until the time of successful groin puncture, assessed up to 12 hours
Secondary outcomes:
measure: Time from arrival to groin puncture
timeFrame: From the time of arrival at the emergency department until the time of successful groin puncture, assessed up to 12 hours
measure: Time from arrival to imaging
timeFrame: From the time of arrival at the emergency department until the time of brain imaging, assessed up to 12 hours
measure: Time from imaging to groin puncture
timeFrame: From the time of brain imaging until the time of successful groin puncture, assessed up to 12 hours
measure: Time from groin puncture to recanalization
timeFrame: From the time of successful groin puncture until the time of the recanalization of the occluded artery, assessed up to 4 hours
measure: Time from arrival to recanalization
timeFrame: From the time of arrival at the emergency department until the time of the recanalization of the occluded artery, assessed up to 48 hours
measure: Time from symptom onset to recanalization
timeFrame: From the time of symptom onset until the time of of the recanalization of the occluded artery, assessed up to 48 hours
measure: Recanalization rate immediately after the procedure
timeFrame: Immediately after the procedure
measure: Recanalization rate 24 hours after the procedure
timeFrame: 24 hours after the procedure
measure: Modified Rankin Scale independence rate within 90 days after the procedure
timeFrame: 90 days after enrolment
measure: EQ-5D-3L 90 days after the procedure
timeFrame: 90 days after the procedure
measure: Rate of symptomatic intracerebral hemorrhage within 24 hours after the procedure
timeFrame: 24 hours within the procedure ended
measure: Rate of complications related to the procedure
timeFrame: 24 hours after the procedure
measure: Rate of all cause mortality within 90 days after the procedure
timeFrame: 90 days after enrolment
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital
state: Beijing
Study officials:
References: