NCT Number: NCT05659160
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).
Interested in participating?
Request Info18 year and older
All sexes
Observational
Beijing University Binhai Hospital, Tianjin, Tianjin Municipality, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 90 days
A 0-6 scale running from perfect health without symptoms to death.
Time frame: 90 days
mortality of any causes.
Time frame: 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.
Time frame: 14 days postoperatively
Periprocedural complications include any intracranial hemorrhage, cerebral edema, brain herniation and pneumonia.
Time frame: Day 0
ASPECTS is a 10-point quantitative topographic CT scan score used in patients with middle cerebral artery (MCA) stroke.
Time frame: 1 year
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.
Contact information is provided by the study sponsor or research team.
Tianjin Huanhu Hospital
Other
Triage of Patients With Acute Ischemic Stroke Due to Large Vessel Occlusions-2 (TRACK-LVO-2): an Imaging-based Patient Registry Study
Acronym: TRACK-LVO-2
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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