Clinical trial NCT06963489: Cerebral Large Vessel Occlusion Stroke Multiomics Biosample Cohort
Official title: Cerebral Large Vessel Occlusion Stroke Multiomics Biosample Cohort
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Large Vessel Occlusion
Acute Ischemic Stroke
Keywords: multiomics
acute ischemic stroke with large vessel occlusion
Lead sponsor: First Affiliated Hospital of Wannan Medical College
Sponsor class: OTHER
Collaborators: name: Beijing Tiantan Hospital
name: The First Affiliated Hospital of Zhengzhou University
name: Baotou Central Hospital
name: Affiliated Hospital of Shandong University of Traditional Chinese Medicine Hospital
First posted: 2025-05-09
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We include patients with acute large vessel occlusion ischemic stroke from at least 5 stroke centers in China.

Brief summary: 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).

Detailed description: 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

Eligibility criteria: 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.

Primary outcomes:
measure: Number of patients with futile recanalization
timeFrame: From enrollment to 3 month follow-up
Secondary outcomes:
measure: Number of patients with specific stroke etiologies
timeFrame: Baseline
measure: Number of patients with hemorrhagic transformation
timeFrame: 7 days within stroke onset
measure: Number of patients with infarct expansion
timeFrame: Baseline
Other outcomes:
Locations:
city: Wuhu
country: China
facility: The First Affiliated Hospital of Shihezi University
state: Anhui
city: Baotou
country: China
facility: Baotou Central Hospital
state: Inner Mongolia
city: Jinan
country: China
facility: Affiliated Hospital of Shandong University of Traditional Chinese Medicine Hospital
state: Shandong
city: Henan
country: China
facility: The First Affiliated Hospital of zhengzhou University
state: Zhengzhou
city: Beijing
country: China
facility: Capital medical university of Beijing Tiantan Hospital
Study officials:
References:
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