Triage of Patients With Acute Ischemic Stroke Due to Large Vessel Occlusions-1 (TRACK-LVO-1)

NCT ID: NCT05885178

Last Updated: 2023-11-29

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 5000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-01-01
• Study Completion Date: 2025-01-01

Brief Summary

The aim of this study is to establish an academic, real-world, single-center, observational registry of consecutive patients hospitalized with acute ischemic stroke (AIS) due to large vessel occlusions (LVO), treated with either endovascular therapy (EVT) or best medical management (BMM).

Detailed Description

Stroke is a major threat to public health and is exacerbating socioeconomic development. It is the leading cause of mortality among residents in China. Large vessel occlusion (LVO) is a predictor of unfavorable outcomes and can account for up to 52% of patients with acute ischemic stroke (AIS). The definition of LVO and its optimal screening imaging modalities remain controversial. In this registry, the investigators defined LVO as an occlusion of the intracranial ICA with or without the involvement of the terminal bifurcation, M1 and/or M2 segment of the MCA, A1 and/or A2 segment of the ACA, VA, BA, or P1 and/or P2 segment of the PCA.

TRACK-LVO is an academic, real-world, single-center, observational registry, in which consecutive patients hospitalized with AIS due to LVO will be treated with either EVT or BMM. Baseline information and clinical follow-up information at 90 days from stroke onset are collected. The key baseline items in this registration for both EVT and BMM groups include basic demographic profiles, past medical history, NIHSS score, treatment with intravenous alteplase, type of stroke onset, time from stroke onset to admission/imaging, imaging characteristics such as the volume of the ischemic core and occlusion site, and treatment-related complications. Additional information collected in EVT groups includes details of EVT procedure and angiographic images.

The investigators enrolled patients with LVO screened under different imaging modalities to further reveal the optimal imaging modalities in the detection of LVO. The investigators also tend to compare the prognosis of AIS patients with LVO receiving endovascular therapy and the best medical management respectively.

Conditions

Stroke, Acute Ischemic; Endovascular Procedures; Large Vessel Occlusion

Keywords

Acute Ischemic Stroke; Endovascular Therapy; Large Vessel Occlusion

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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.

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.

Interventions

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

Inclusion Criteria

1. Patient admitted from Jan. 1st, 2018 to June. 1st, 2021;

2. Age ≥ 18;

3. Ischemic stroke confirmed by head CT or MRI;

4. Large vessel occlusion confirmed by head CTA or MRA: intracranial internal carotid artery (ICA), middle cerebral artery (MCA M1/M2), anterior cerebral artery (ACA A1/A2), basilar artery (BA), vertebral artery (VA), and posterior cerebral artery (PCA P1/P2);

5. Patients receiving either endovascular therapy or best medical treatment;

Exclusion Criteria

-

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tianjin Huanhu Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ming Wei

Chief Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Tianjin Huanhu Hospital

Tianjin, Tianjin Municipality, China

Countries

China

Other Identifiers

TJHH-2023-WeiMing

Identifier Type: -

Identifier Source: org_study_id