Clinical trial NCT06200753: Triage of Patients Presenting Beyond 24 Hours With Acute Ischemic Stroke Due to Large Vessel Occlusions (TRACK-LVO Late)
Official title: Triage of Patients Presenting Beyond 24 Hours From Last Known Well With Acute Ischemic Stroke Due to Large Vessel Occlusions (TRACK-LVO Late): a TRACK-LVO Registry-linked Cohort
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Endovascular Thrombectomy
Large Vessel Occlusion
Acute Ischemic Stroke
Keywords: Acute Ischemic Stroke, Endovascular Therapy,
Lead sponsor: Tianjin Huanhu Hospital
Sponsor class: OTHER
First posted: 2024-01-11
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Acute stroke patients with large vessel occlusion and presenting beyond 24 hours from last known well

Brief summary: The objective of this study is to create a comprehensive, multi-center, TRACK-LVO registry-linked cohort of consecutive patients with acute ischemic stroke (AIS) caused by large vessel occlusions (LVO) and presenting to each participating center beyond 24 hours from last known well, who are treated with either endovascular therapy (EVT) or the best available medical management (BMM).

Detailed description: There is an abundance of evidence demonstrating the efficacy and safety of endovascular therapy (EVT) within 24 hours of stroke onset. However, the potential benefits of EVT beyond this time window remain uncertain. To address this knowledge gap, the investigators established a TRACK-LVO Late linked cohort, specifically designed to investigate the outcomes of EVT in patients with LVO presenting beyond 24 hours from last known well.

This cohort includes patients from the TRACK-LVO registry who received either EVT or best medical treatment (BMT) beyond 24 hours from symptom onset. The cohort focuses on patients with LVO in the anterior circulation, confirmed by magnetic resonance angiography (MRA), computed tomography angiography (CTA), or digital subtraction angiography (DSA) in the EVT group. To maximize the sample size in the BMT group, the investigators also included patients with LVO confirmed using transcranial Doppler and carotid ultrasonography, in addition to the aforementioned imaging modalities.

Consistent with the TRACK-LVO registry, LVO is defined as an occlusion of the intracranial internal carotid artery (ICA) , M1 and/or M2 segments of the middle cerebral artery (MCA), A1 and/or A2 segments of the anterior cerebral artery (ACA), any segments of vertebral artery (VA), basilar artery (BA), or P1 and/or P2 segments of the posterior cerebral artery (PCA).

The investigators collect comprehensive patient information, including baseline demographic profiles, imaging characteristics such as ischemic core volume and FVH-DWI mismatch, CT/MR perfusion parameters, and treatment-related complications, for both EVT and BMT groups. For patients in the EVT group, the investigators also obtained detailed information on the EVT procedure and angiographic images.

By establishing this cohort, the investigators aim to provide high-level evidence to guide the treatment of a subgroup of stroke patients who present beyond the current guideline-recommended time window for EVT. The findings will contribute to determining the superiority of EVT over BMT in ischemic stroke patients with LVO and extended time from symptom onset.

Eligibility criteria: Inclusion Criteria:

* Patient admitted from Jan. 1st 2018 to Jan. 1st 2028;
* Presenting beyond 24 hours from last known well;
* 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:

• Presence of any forms of cerebral hemorrhage on CT/MR at admission.

Primary outcomes:
measure: Modified ranking scale (mRS) at 90 days
timeFrame: 90 days
measure: symptomatic intracranial hemorrhage
timeFrame: 72 hours
Secondary outcomes:
measure: National Institutes of Health Stroke Scale (NIHSS) scores at 90 days
timeFrame: 1, 3, 5 (or discharge), 7 (or discharge) and 90 days
measure: Occurrence of periprocedural complications
timeFrame: 72 hours
measure: EuroQol five dimensions questionnaire (EQ-5D)
timeFrame: 1 year
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Huanhu Hospital
state: Tianjin
Study officials:
References: