Triage of Patients With Acute Ischemic Stroke Due to Large Vessel Occlusions-2

Stroke, Acute Ischemic Clinical Trial

— TRACK-LVO-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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05659160
• Other study ID #: TJHH-2022-WM12
• Status: Recruiting
• Start date: November 1, 2021
• Est. completion date: December 31, 2028

Study information

• Verified date: November 2023
• Source: Tianjin Huanhu Hospital
• Contact: Ming Wei, PhD
• Phone: 13502182903
• Email: drweiming[@]163.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: December 31, 2028
• Est. primary completion date: December 31, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

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	Beijing University Binhai Hospital	Tianjin	Tianjin
China	The Sencond Hospital of Tianjin Medical University	Tianjin	Tianjin
China	Tianjin Huanhu Hospital	Tianjin	Tianjin
China	Tianjin Medical University General 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 (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
Secondary	EuroQol five dimensions questionnaire (EQ-5D)	The EQ-5D comprises five questions on mobility, self care, pain, usual activities, and psychological status with three possible answers for each item (1=no problem, 2=moderate problem, 3=severe problem). A summary index with a maximum score of 1 can be derived from these five dimensions by conversion with a table of scores. The maximum score of 1 indicates the best health state, by contrast with the scores of individual questions, where higher scores indicate more severe or frequent problems.	1 year