Triage of Patients With Acute Ischemic Stroke Due to Large Vessel Occlusions-1 (TRACK-LVO-1)

Stroke, Acute Ischemic Clinical Trial

— TRACK-LVO-1  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05885178
• Other study ID #: TJHH-2023-WeiMing
• Status: Enrolling by invitation
• Start date: January 1, 2018
• Est. completion date: January 1, 2025

Study information

• Verified date: November 2023
• Source: Tianjin Huanhu Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 5000
• Est. completion date: January 1, 2025
• Est. primary completion date: November 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patient admitted from Jan. 1st, 2018 to June. 1st, 2021;

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:

-

Related Conditions & MeSH terms

• Endovascular Procedures
• Ischemia
• Ischemic Stroke
• Large Vessel Occlusion
• Stroke

Intervention

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.

Locations

Country	Name	City	State
China	Tianjin Huanhu Hospital	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Huanhu Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modified ranking scale (mRS) at 90 days	A 0-6 scale running from perfect health without symptoms to death.	90 days
Primary	Mortality within 90 days	mortality of any causes.	90 days
Secondary	National Institutes of Health Stroke Scale (NIHSS) scores at 90 days	The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score being a 0.	90 days
Secondary	Occurrence of periprocedural complications	Periprocedural complications include any intracranial hemorrhage, cerebral edema, brain herniation and pneumonia.	14 days postoperatively
Secondary	ASPECT score (Alberta Stroke Program Early CT score)	ASPECTS is a 10-point quantitative topographic CT scan score used in patients with middle cerebral artery (MCA) stroke.	Day 0