Cerebral Large Vessel Occlusion Stroke Multiomics Biosample Cohort

First Affiliated Hospital of Wannan Medical College500 enrolled

Overview

This multicenter, ambispective cohort study establishes a comprehensive multiomics biobank from five stroke centers, encompassing thrombi, intracranial blood, peripheral arterial/venous blood, and clinical-laboratory-imaging-follow-up data from patients with acute ischemic stroke with large vessel occlusion (AIS-LVO).

This study is a multicenter, ambispective cohort study. Blood clot, peripheral arterial blood, peripheral venous blood, and intracranial blood samples were collected from patients at 5 stroke centers to establish a biobank of patients with AIS-LVO. Blood and thrombus samples underwent pathological analysis, metabolomics, proteomics, and genomics for multidimensional testing. Additionally, clinical, laboratory, follow-up, and imaging data were collected. The main objective is to identify phenotypic differences between intracranial blood and peripheral blood, describe the microenvironment profile, and perform a combined analysis of the thrombus' multi-omics phenotypes to construct a "microenvironment" multiomics fingerprint. Furthermore, based on the multi-omics phenotypic components of thrombus and blood, clinical prediction models will be built. These models will address clinical issues related to etiology diagnosis, risk stratification, and prognosis in large vessel occlusion stroke patients, using external or internal validation methods. For a subset of patients, thrombus samples will undergo pathological processing and histological examination, followed by joint analysis with multi-omics data. The CLOMB study was designed to collect multidimensional clinical and multiomics data of AIS-LVO patients. The rich data set with deep phenotypes and multiomics analysis of patients will facilitate the study of more stroke-related scientific questions, which include but not limit to the following: 1. Thrombus and microenvironment multiomics profiles 2. Identification of post-stroke therapeutic target 3. Establishing new prediction and risk stratification models based on multiomics data 4. Exploring new diagnostic approach for AIS-LVO etiologies

Study Type

OBSERVATIONAL

Enrollment

500

Conditions

Large Vessel Occlusion Acute Ischemic Stroke

Interventions

Not applicable- observational studyOTHER

Intervention is not applicable

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age over 18 years. 2. Patients with intracranial and extracranial large vessel occlusion ischemic stroke confirmed by cerebrovascular angiography. 3. Availability of complete clinical and follow-up information required for the study. 4. Availability of blood and/or thrombus biological samples. 5. Voluntary written informed consent signed by the patient or their family (1) For retrospectively enrolled patients, a "broad informed consent" was signed at the time of sample collection. Upon enrollment into the cohort, a follow-up phone call was made to confirm the informed consent. (2) For prospectively enrolled patients, informed consent for this study was signed at the time of enrollment by the patient or their family. Exclusion Criteria: 1. Patients for whom biological samples cannot be obtained; 2. Patients or their family members who refuse to sign the informed consent form.

Locations (5)

The First Affiliated Hospital of Shihezi University

Wuhu, Anhui, China

NOT_YET_RECRUITING

Baotou Central Hospital

Baotou, Inner Mongolia, China

RECRUITING

Affiliated Hospital of Shandong University of Traditional Chinese Medicine Hospital

Jinan, Shandong, China

Outcomes

Primary Outcomes

Number of patients with futile recanalization

mRS score ≥3 at 3 months

Time frame: From enrollment to 3 month follow-up

Secondary Outcomes

Number of patients with specific stroke etiologies

Patients will be classified as Cardioembolism or Large artery atherosclerosis as a final stroke etiology.

Time frame: Baseline

Number of patients with hemorrhagic transformation

HT: secondary occurrence of bleeding within an area of the brain affected by ischemic stroke (cerebral infarction). Further stratified into: 1. symptomatic intracranial hemorrhage (sICH) and asymptomatic intracranial hemorrhage (aICH) 2. different extent: HI1, HI2, PH1, PH2

Time frame: 7 days within stroke onset

Number of patients with infarct expansion

Patients undergoing thrombectomy had their CTAVP reexamined 24 hours later. Through CTP, it was determined whether the volume of the infarcted lesion (rCBF\<30%) had expanded compared with preoperative CTP.

Time frame: Baseline

Central Contacts

Zhiyuan Feng, MD

CONTACT

86+15801290121 fzyhhz1996@gmail.com

Data from ClinicalTrials.gov

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