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NCT Number: NCT06963489

Cerebral Large Vessel Occlusion Stroke Multiomics Biosample Cohort

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).

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Affiliated Hospital of Shihezi University, Wuhu, Anhui, China

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About this study

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:

  • Thrombus and microenvironment multiomics profiles
  • Identification of post-stroke therapeutic target
  • Establishing new prediction and risk stratification models based on multiomics data
  • Exploring new diagnostic approach for AIS-LVO etiologies

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age over 18 years.
  • Patients with intracranial and extracranial large vessel occlusion ischemic stroke confirmed by cerebrovascular angiography.
  • Availability of complete clinical and follow-up information required for the study.
  • Availability of blood and/or thrombus biological samples.
  • 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

  • Patients for whom biological samples cannot be obtained;
  • Patients or their family members who refuse to sign the informed consent form.

Treatment and study plan

Not applicable- observational study

Other

Intervention is not applicable

Primary outcomes

  1. Number of patients with futile recanalization

    Time frame: From enrollment to 3 month follow-up

    mRS score ≥3 at 3 months

Secondary outcomes

  1. Number of patients with specific stroke etiologies

    Time frame: Baseline

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

  2. Number of patients with hemorrhagic transformation

    Time frame: 7 days within stroke onset

    HT: secondary occurrence of bleeding within an area of the brain affected by ischemic stroke (cerebral infarction).

    Further stratified into:

    • symptomatic intracranial hemorrhage (sICH) and asymptomatic intracranial hemorrhage (aICH)
    • different extent: HI1, HI2, PH1, PH2
  3. Number of patients with infarct expansion

    Time frame: Baseline

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Zhiyuan Feng, MD

CONTACT

[email protected]

86+15801290121

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Wannan Medical College

Other

Collaborators

  • Affiliated Hospital of Shandong University of Traditional Chinese Medicine
  • Baotou Central Hospital
  • Beijing Tiantan Hospital
  • The First Affiliated Hospital of Zhengzhou University

Registry information

Acronym: CLOMB

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
May 9, 2025
Registry last updated
May 11, 2025

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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