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Intracranial Artery Occlusion With Infarction (Disorder)ANGEL-ACT IINCT04151589

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

A study testing ANGEL Intervention Package and Toolbox in people with Intracranial Artery Occlusion With Infarction (Disorder), run by Beijing Tiantan Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
ANGEL Intervention Package and Toolbox
Could I receive a placebo?
No, everyone receives an active treatment
How many people
664 participants
Where
1 siteChina
Study dates
22 Aug 2019to 30 Jun 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

1 site in 1 country.

China1 site, 1 recruiting

  • Beijing Tiantan Hospital

    Beijing, Beijing Municipality, 100010

    Zhongrong Miao, PhD,MD, 13601243293, 13601243293@163.com

    Recruiting

Other trials in China

About this study

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

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.

Read the 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.

Being tested
ANGEL Intervention Package and Toolbox

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ANGEL Intervention Package and ToolboxBehavioural

    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.

Study groups in NCT04151589
Study groupRoleWhat they receive
Interventional SiteExperimentalThe process below will be allocated in Interventional Sites: 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.
Receives: Behavioral: ANGEL Intervention Package and Toolbox
Control SiteNo interventionThe control site would not undergo any emergency work flow modification for acute ischemic stroke patients who eligible for endovascular treatment.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: From the time of arrival at the emergency department until the time of successful groin puncture, assessed up to 12 hours

Secondary outcomes (13)

  1. Time from arrival to groin puncture

    Minutes

    Measured: From the time of arrival at the emergency department until the time of successful groin puncture, assessed up to 12 hours

  2. Time from arrival to imaging

    Minutes

    Measured: From the time of arrival at the emergency department until the time of brain imaging, assessed up to 12 hours

  3. Time from imaging to groin puncture

    Minutes

    Measured: From the time of brain imaging until the time of successful groin puncture, assessed up to 12 hours

  4. Time from groin puncture to recanalization

    Minutes

    Measured: From the time of successful groin puncture until the time of the recanalization of the occluded artery, assessed up to 4 hours

  5. Time from arrival to recanalization

    Minutes

    Measured: From the time of arrival at the emergency department until the time of the recanalization of the occluded artery, assessed up to 48 hours

  6. Time from symptom onset to recanalization

    Minutes

    Measured: From the time of symptom onset until the time of of the recanalization of the occluded artery, assessed up to 48 hours

  7. Recanalization rate immediately after the procedure

    modified thrombolysis in cerebral infarction (mTICI) 2b-3

    Measured: Immediately after the procedure

  8. Recanalization rate 24 hours after the procedure

    Recanalization was defined as a thrombolysis in myocardial infarction (TIMI ) score of 2- 3.

    Measured: 24 hours after the procedure

  9. 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.

    Measured: 90 days after enrolment

  10. 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.

    Measured: 90 days after the procedure

  11. Rate of symptomatic intracerebral hemorrhage within 24 hours after the procedure

    Measured: 24 hours within the procedure ended

  12. Rate of complications related to the procedure

    Measured: 24 hours after the procedure

  13. Rate of all cause mortality within 90 days after the procedure

    Measured: 90 days after enrolment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Nov 2019
  2. Study start22 Aug 2019
  3. Primary completion31 Dec 2020 (estimated)
  4. Study completion30 Jun 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
664 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04151589
Sponsor's protocol ID
2016YFC1301501-2
Acronym
ANGEL-ACT II
Status last verified
Nov 2019
First submitted
1 Nov 2019
Last updated
13 Nov 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing ANGEL Intervention Package and Toolbox in people with Intracranial Artery Occlusion With Infarction (Disorder), run by Beijing Tiantan Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 13 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of reaching the standard arrival-to-groin Puncture time (time frame: From the time of arrival at the emergency department until the time of successful groin puncture, assessed up to 12 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04151589.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2019.

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