Medical Imaging Screening for Posterior-circulation Ischemic Stroke

Medical Imaging Screening for Posterior-circulation Ischemic Stroke：a Multicentre,Imaging-based,Prospective Cohort Study

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.

Study Overview

• Status: Recruiting
• Conditions: Endovascular Thrombectomy
• Intervention / Treatment: Procedure: Endovascular Therapy

Detailed Description

• 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.

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Ming Wei, PhD; Phone Number: 13502182903; Email: drweiming@163.com

Study Locations

• China
  • Tianjin
    • Tianjin, Tianjin, China, 300052
      • Recruiting
      • Tianjin Medical University General Hospital
      • Contact: Xuanye Yue, MD; Phone Number: 022-60814622; Email: yuexy2002@aliyun.com
      • Principal Investigator: Xuanye Yue, MD
    • Tianjin, Tianjin, China, 300222
      • Recruiting
      • Tianjin Huanhu Hospital
      • Principal Investigator: Ming Wei, PhD
      • Contact: Ming Wei, PhD; Phone Number: 13502182903; Email: drweiming@163.com
    • Tianjin, Tianjin, China, 300211
      • Recruiting
      • The Sencond Hospital of Tianjin Medical University
      • Contact: Zhenjian Ma, MD; Phone Number: 18322412226; Email: mazhenjian@126.com
      • Principal Investigator: Zhenjian Ma, MD
    • Tianjin, Tianjin, China, 300450
      • Recruiting
      • Beijing University Binhai Hospital
      • Contact: Wanchao Shi, MD; Phone Number: 15620177339; Email: swc9801@sina.com
      • Principal Investigator: Wanchao Shi, MD
      • Contact: Phone Number: Wanchao

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All acute ischemic strvoke patients with vertebrobasilar artery occlusion.

Description

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).

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Endovascular therapy; Timely thrombectomy for acute ischemic stroke patients with large vessel occlusion by either stent retriever, thrombus aspiration, others, or combination methods.	Procedure: 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
Best medical management; Patients enrolled in this group received the best medical management.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified ranking scale (mRS) at 90 days	A 0-6 scale running from perfect health without symptoms to death.	90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality within 90 days	mortality of any causes.	90 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
National Institutes of Health Stroke Scale (NIHSS) scores at 90 days	The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score being a 0.	90 days
Occurrence of periprocedural complications	Periprocedural complications include any intracranial hemorrhage, cerebral edema, brain herniation and pneumonia.	90 days
pc-ASPECT (posterior circulation Alberta Stroke Program Early CT score)	pc-ASPECTS is a 10-point quantitative topographic CT scan score used in patients with posterior circulation stroke.	0 days

Collaborators and Investigators

• Sponsor: Tianjin Huanhu Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2019
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: October 16, 2023
• First Submitted That Met QC Criteria: October 16, 2023
• First Posted (Actual): October 23, 2023

Study Record Updates

• Last Update Posted (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: October 16, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: magnetic resonance imaging; endovascular thrombectomy; diffusion weighted imaging; select patients; Vertebrobasilar artery
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke
• Other Study ID Numbers: TJHH-2023-wm14

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