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Clinical Trials/NCT05659160
NCT05659160
Recruiting
Not Applicable

Triage of Patients With Acute Ischemic Stroke Due to Large Vessel Occlusions-2 (TRACK-LVO-2): an Imaging-based Patient Registry Study

Tianjin Huanhu Hospital4 sites in 1 country5,000 target enrollmentNovember 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke, Acute Ischemic
Sponsor
Tianjin Huanhu Hospital
Enrollment
5000
Locations
4
Primary Endpoint
Mortality within 90 days
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

The objective of this study is to create a comprehensive, real-world, multi-center observational registry of consecutive patients admitted to hospitals with acute ischemic stroke (AIS) caused by large vessel occlusions (LVO), who are treated with either endovascular therapy (EVT) or the best available medical management (BMM).

Detailed Description

The TRACK-LVO registry is an observational study conducted across multiple centers with the aim of improving the detection and treatment of large vessel occlusion (LVO) in acute ischemic stroke (AIS) patients. LVO is a major predictor of unfavorable outcomes in stroke patients, and the most effective imaging modalities for its detection remain a topic of debate. To address this, the investigators will enroll consecutive AIS patients with LVO screened under different imaging modalities and compared the efficacy of endovascular therapy (EVT) and best medical management (BMM). The registry defines 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. Patient information, including basic demographic profiles, imaging characteristics such as volume of ischemic core and occlusion site, and treatment-related complications will be collected for both EVT and BMM groups. For patients in the EVT group, detailed information on the EVT procedure and angiographic images will also be collected. The study aims to identify the optimal imaging modalities for LVO detection and to compare the prognosis of AIS patients with LVO receiving EVT versus BMM. This academic, real-world, multi-center, observational registry will contribute valuable insights to improve the detection and treatment of LVO in AIS patients, ultimately improving patient outcomes and reducing the burden of stroke on public health and socio-economic development.

Registry
clinicaltrials.gov
Start Date
November 1, 2021
End Date
December 31, 2028
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 Jan. 1st 2028;
  • 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

Mortality within 90 days

Time Frame: 90 days

mortality of any causes.

Modified ranking scale (mRS) at 90 days

Time Frame: 90 days

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

Secondary Outcomes

  • ASPECT (Alberta Stroke Program Early CT score)(Day 0)
  • National Institutes of Health Stroke Scale (NIHSS) scores at 90 days(90 days)
  • Occurrence of periprocedural complications(14 days postoperatively)
  • EuroQol five dimensions questionnaire (EQ-5D)(1 year)

Study Sites (4)

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