Clinical trial NCT05659160: Triage of Patients With Acute Ischemic Stroke Due to Large Vessel Occlusions-2
Official title: Triage of Patients With Acute Ischemic Stroke Due to Large Vessel Occlusions-2 (TRACK-LVO-2): an Imaging-based Patient Registry Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stroke, Acute Ischemic
Endovascular Procedures
Large Vessel Occlusion
Keywords: Acute Ischemic Stroke
Endovascular Therapy
Large Vessel Occlusion
Lead sponsor: Tianjin Huanhu Hospital
Sponsor class: OTHER
First posted: 2022-12-21
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All acute ischemic stroke patients with large vessel occlusion.

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.

Eligibility criteria: Inclusion Criteria:

1. Patient admitted from Jan. 1st 2018 to Jan. 1st 2028;
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:

- None

Primary outcomes:
measure: Modified ranking scale (mRS) at 90 days
timeFrame: 90 days
measure: Mortality within 90 days
timeFrame: 90 days
Secondary outcomes:
measure: National Institutes of Health Stroke Scale (NIHSS) scores at 90 days
timeFrame: 90 days
measure: Occurrence of periprocedural complications
timeFrame: 14 days postoperatively
measure: ASPECT (Alberta Stroke Program Early CT score)
timeFrame: Day 0
measure: EuroQol five dimensions questionnaire (EQ-5D)
timeFrame: 1 year
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
state: Tianjin
city: Tianjin
country: China
facility: The Sencond Hospital of Tianjin Medical University
state: Tianjin
city: Tianjin
country: China
facility: Tianjin Huanhu Hospital
state: Tianjin
city: Tianjin
country: China
facility: Beijing University Binhai Hospital
state: Tianjin
Study officials:
References: