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Cerebral Large Vessel Occlusion Stroke Multiomics Biosample Cohort

Cerebral Large Vessel Occlusion Stroke Multiomics Biosample Cohort

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06963489
Acronym
CLOMB
Enrollment
500
Registered
2025-05-09
Start date
2025-04-27
Completion date
2028-02-29
Last updated
2025-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Ischemic Stroke, Large Vessel Occlusion

Keywords

multiomics, acute ischemic stroke with large vessel occlusion

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

Interventions

OTHERNot applicable- observational study

Intervention is not applicable

Sponsors

Beijing Tiantan Hospital
CollaboratorOTHER
The First Affiliated Hospital of Zhengzhou University
CollaboratorOTHER
Baotou Central Hospital
CollaboratorOTHER
Affiliated Hospital of Shandong University of Traditional Chinese Medicine
CollaboratorOTHER
First Affiliated Hospital of Wannan Medical College
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Number of patients with futile recanalizationFrom enrollment to 3 month follow-upmRS score ≥3 at 3 months

Secondary

MeasureTime frameDescription
Number of patients with specific stroke etiologiesBaselinePatients will be classified as Cardioembolism or Large artery atherosclerosis as a final stroke etiology.
Number of patients with hemorrhagic transformation7 days within stroke onsetHT: 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
Number of patients with infarct expansionBaselinePatients 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.

Countries

China

Contacts

Primary ContactZhiyuan Feng, MD
fzyhhz1996@gmail.com86+15801290121

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 9, 2026