Medical Imaging Screening for Posterior-circulation Ischemic Stroke

NCT ID: NCT06094569

Last Updated: 2023-10-23

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

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-06-01

Study Completion Date

2029-12-31

Brief Summary

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Patients with ischemic stroke in the posterior circulation continue to have high rates of mortality and disability, even with aggressive treatment. We wanted to evaluate preoperative imaging to screen patients with a good prognosis from mechanical embolization. We assess the degree of ischemia by defining the pons-midbrain-medulla index (PMMI) and correlate the preoperative PMMI with the clinical prognosis of postoperative patients to verify the validity of PMMI in predicting the clinical prognosis of patients with embolization.

Detailed Description

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* The ENDOSTROKE registry (Endovascular Stroke T reatment Registry), the use of MRI before EVT was associated with significantly better clinical outcomes as compared to CT.
* The purpose of the study will sift patients with posterior circulation ischemia stroke who will get better outcome by Mechanical Thrombectomy by neuroimaging.Specifically, the following assumption will be evaluated: the modified pons-midbrain index in magnetic resonance imaging can predict the clinical outcome of patients with basilar artery thrombosis 90 days after surgery, and can guide whether patients will undergo mechanical thrombectomy later.
* Pons-midbrain-medulla index (PMMI) : We divide pons-midbrain-medulla into the left and right sides by the median line of the brainstem,so we will evaluate ischemia of these six layers which are endowed different score according to the degree of ischemia. Instead of the previous pons-midbrain index (PMI), we select the image layer that shows the largest infarct size among the six parts.Then,we add up six scores that is patient's PMMI. Scoring criteria: At the layer of displaying the maximum infarct size, 2 points are scored if the infarct size exceeds 50% of the total area, 1 point is scored if the infarct size is less than 50% of the total area, and 0 points are scored if there is no infarct.Finally, PMMI values range from 0 to 12 points.
* The investigators conduct a multicenter, prospective cohort study.Preoperative images of patients are evaluated by different groups of imaging physicians to describe the association between preoperative PMMI and clinical prognosis in patients with posterior circulation stroke and to verify its validity.

Conditions

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Endovascular Thrombectomy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Endovascular therapy

Timely thrombectomy for acute ischemic stroke patients with large vessel occlusion by either stent retriever, thrombus aspiration, others, or combination methods.

Endovascular Therapy

Intervention Type PROCEDURE

Endovascular therapy, as an adjunct to standard stroke therapy, may be beneficial for a very select population of patients who present with an acute ischemic stroke and have a proven large, proximal occlusion on imaging. Endovascular therapy includes any one or more of the following: Intra-arterial thrombolytic therapy, aspiration, stent retrieval, or a combination of multiple mechanical devices

Best medical management

Patients enrolled in this group received the best medical management.

No interventions assigned to this group

Interventions

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Endovascular Therapy

Endovascular therapy, as an adjunct to standard stroke therapy, may be beneficial for a very select population of patients who present with an acute ischemic stroke and have a proven large, proximal occlusion on imaging. Endovascular therapy includes any one or more of the following: Intra-arterial thrombolytic therapy, aspiration, stent retrieval, or a combination of multiple mechanical devices

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Patient admitted from Jun. 1st 2019 to Jan. 1st 2029;
2. Patients with acute ischemic stroke recently;
3. Symptoms persisted at admission, and MRI (including DWI) confirmed acute ischemic vertebrobasilar artery occlusion in the posterior circulation:(single right or left intracranial branch of vertebral artery occlusion ; single basilar occlusion ; both two vertebral arterys and basilar artery);

Exclusion Criteria

1.Patiens can not meet the MRI examination conditions(with absolute and relative contraindications).
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tianjin Huanhu Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ming Wei

Chief Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, China

Site Status RECRUITING

The Sencond Hospital of Tianjin Medical University

Tianjin, Tianjin Municipality, China

Site Status RECRUITING

Tianjin Huanhu Hospital

Tianjin, Tianjin Municipality, China

Site Status RECRUITING

Beijing University Binhai Hospital

Tianjin, Tianjin Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Ming Wei, PhD

Role: CONTACT

13502182903

Facility Contacts

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Xuanye Yue, MD

Role: primary

022-60814622

Zhenjian Ma, MD

Role: primary

18322412226

Ming Wei, PhD

Role: primary

13502182903

Wanchao Shi, MD

Role: primary

15620177339

Role: backup

Wanchao

Other Identifiers

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TJHH-2023-wm14

Identifier Type: -

Identifier Source: org_study_id

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