Triage of Patients With Acute Ischemic Stroke Due to Large Vessel Occlusions-2
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Endovascular Therapy.
- Who it may be relevant to
- Registry conditions: Stroke, Acute Ischemic, Endovascular Procedures, Large Vessel Occlusion. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Triage of Patients With Acute Ischemic Stroke Due to Large Vessel Occlusions-2 (TRACK-LVO-2): an Imaging-based Patient Registry Study
Overview
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.
Interventions
- 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.
Primary outcome measures
- Modified ranking scale (mRS) at 90 days [Time frame: 90 days]
- Mortality within 90 days [Time frame: 90 days]
Secondary outcome measures (4)
- National Institutes of Health Stroke Scale (NIHSS) scores at 90 days [Time frame: 90 days]
- Occurrence of periprocedural complications [Time frame: 14 days postoperatively]
- ASPECT (Alberta Stroke Program Early CT score) [Time frame: Day 0]
- EuroQol five dimensions questionnaire (EQ-5D) [Time frame: 1 year]
Eligibility criteria
Inclusion criteria
- Patient admitted from Jan. 1st 2018 to Jan. 1st 2028;
- Age ≥ 18;
- 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
\- None
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 4 centers
- Tianjin Medical University General Hospital — Tianjin
- The Sencond Hospital of Tianjin Medical University — Tianjin
- Tianjin Huanhu Hospital — Tianjin
- Beijing University Binhai Hospital — Tianjin
Identifiers
NCT: NCT05659160 · TJHH-2022-WM12