Medical Imaging Screening for Posterior-circulation Ischemic Stroke

NCT06094569 | Recruiting DMC

• 1 other identifier: TJHH-2023-wm14
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Endovascular Thrombectomy

Keywords

select patients; endovascular thrombectomy; magnetic resonance imaging; diffusion weighted imaging; Vertebrobasilar artery

Outcome Measures

Primary Outcomes (1)

• Modified ranking scale (mRS) at 90 days

  A 0-6 scale running from perfect health without symptoms to death.

  90 days

Secondary Outcomes (1)

• Mortality within 90 days

  90 days

Other Outcomes (3)

• National Institutes of Health Stroke Scale (NIHSS) scores at 90 days

  90 days

• Occurrence of periprocedural complications

  90 days

• pc-ASPECT (posterior circulation Alberta Stroke Program Early CT score)

  0 days

Study Arms (2)

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

Best medical management

Patients enrolled in this group received the best medical management.

Interventions

Endovascular Therapy 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

Endovascular therapy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All acute ischemic strvoke patients with vertebrobasilar artery occlusion.

You may qualify if:

• Patient admitted from Jun. 1st 2019 to Jan. 1st 2029;
• Patients with acute ischemic stroke recently；
• 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）；

You may not qualify if:

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

Sponsors & Collaborators

• Tianjin Huanhu Hospital: lead

Study Sites (4)

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, 300052, China

RECRUITING

The Sencond Hospital of Tianjin Medical University

Tianjin, Tianjin Municipality, 300211, China

RECRUITING

Tianjin Huanhu Hospital

Tianjin, Tianjin Municipality, 300222, China

RECRUITING

Beijing University Binhai Hospital

Tianjin, Tianjin Municipality, 300450, China

RECRUITING

Central Study Contacts

Ming Wei, PhD

CONTACT

13502182903; drweiming@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: October 16, 2023
• First Posted: October 23, 2023
• Study Start: June 1, 2019
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: October 23, 2023

Record last verified: 2023-10

Locations

CN (4)