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Clinical Trials/NCT05885178
NCT05885178
Enrolling By Invitation
Not Applicable

Triage of Patients With Acute Ischemic Stroke Due to Large Vessel Occlusions-1 (TRACK-LVO-1): an Imaging-based Patient Registry Study

Tianjin Huanhu Hospital1 site in 1 country5,000 target enrollmentJanuary 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke, Acute Ischemic
Sponsor
Tianjin Huanhu Hospital
Enrollment
5000
Locations
1
Primary Endpoint
Modified ranking scale (mRS) at 90 days
Status
Enrolling By Invitation
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2018
End Date
January 1, 2025
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Tianjin Huanhu Hospital
Responsible Party
Principal Investigator
Principal Investigator

Ming Wei

Chief Physician

Tianjin Huanhu Hospital

Eligibility Criteria

Inclusion Criteria

  • Patient admitted from Jan. 1st, 2018 to June. 1st, 2021;
  • Ischemic stroke confirmed by head CT or MRI;
  • 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);
  • Patients receiving either endovascular therapy or best medical treatment;

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Modified ranking scale (mRS) at 90 days

Time Frame: 90 days

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

Mortality within 90 days

Time Frame: 90 days

mortality of any causes.

Secondary Outcomes

  • National Institutes of Health Stroke Scale (NIHSS) scores at 90 days(90 days)
  • Occurrence of periprocedural complications(14 days postoperatively)
  • ASPECT score (Alberta Stroke Program Early CT score)(Day 0)

Study Sites (1)

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