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Recruiting NCT06963489

Cerebral Large Vessel Occlusion Stroke Multiomics Biosample Cohort

— Observational Large Vessel Occlusion Acute Ischemic Stroke

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Not applicable- observational study.
Who it may be relevant to
Registry conditions: Large Vessel Occlusion, Acute Ischemic Stroke. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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).

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

  • Other Not applicable- observational study
    Intervention is not applicable

Primary outcome measures

  • Number of patients with futile recanalization [Time frame: From enrollment to 3 month follow-up]
Secondary outcome measures (3)
  • Number of patients with specific stroke etiologies [Time frame: Baseline]
  • Number of patients with hemorrhagic transformation [Time frame: 7 days within stroke onset]
  • Number of patients with infarct expansion [Time frame: Baseline]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 5 centers
  • The First Affiliated Hospital of Shihezi University — Wuhu
  • Baotou Central Hospital — Baotou
  • Affiliated Hospital of Shandong University of Traditional Chinese Medicine Hospital — Jinan
  • The First Affiliated Hospital of zhengzhou University — Henan
  • Capital medical university of Beijing Tiantan Hospital — Beijing

Publications

  • Xu X, Song Y, Cao W, Bai X, Wang X, Gao P, Chen J, Chen Y, Yang B, Wang Y, Chen F, Ma Q, Yu B, Jiao L. Alterations of Hemostatic Molecular Markers During Acute Large Vessel Occlusion Stroke. J Am Heart Assoc. 2024 Feb 6;13(3):e032651. doi: 10.1161/JAHA.123.032651. Epub 2024 Jan 31. PMID 38293908
  • Kollikowski AM, Schuhmann MK, Nieswandt B, Mullges W, Stoll G, Pham M. Local Leukocyte Invasion during Hyperacute Human Ischemic Stroke. Ann Neurol. 2020 Mar;87(3):466-479. doi: 10.1002/ana.25665. Epub 2020 Jan 16. PMID 31899551
  • Strinitz M, Pham M, Marz AG, Feick J, Weidner F, Vogt ML, Essig F, Neugebauer H, Stoll G, Schuhmann MK, Kollikowski AM. Immune Cells Invade the Collateral Circulation during Human Stroke: Prospective Replication and Extension. Int J Mol Sci. 2021 Aug 25;22(17):9161. doi: 10.3390/ijms22179161. PMID 34502070
  • Stoll G, Schuhmann MK, Nieswandt B, Kollikowski AM, Pham M. An intravascular perspective on hyper-acute neutrophil, T-cell and platelet responses: Similarities between human and experimental stroke. J Cereb Blood Flow Metab. 2022 Sep;42(9):1561-1567. doi: 10.1177/0271678X221105764. Epub 2022 Jun 8. PMID 35676801
  • Zimmermann L, Pham M, Marz AG, Kollikowski AM, Stoll G, Schuhmann MK. Defining cerebral leukocyte populations in local ischemic blood samples from patients with hyperacute stroke. J Cereb Blood Flow Metab. 2022 May;42(5):901-904. doi: 10.1177/0271678X221078617. Epub 2022 Feb 2. PMID 35107055
  • Dargazanli C, Blaquiere M, Moynier M, de Bock F, Labreuche J, Ter Schiphorst A, Derraz I, Radu RA, Gascou G, Lefevre PH, Rapido F, Fendeleur J, Arquizan C, Bourcier R, Marin P, Machi P, Cagnazzo F, Hirtz C, Costalat V, Marchi N. Inflammation biomarkers in the intracranial blood are associated with outcome in patients with ischemic stroke. J Neurointerv Surg. 2025 Jan 17;17(2):159-166. doi: 10.1136 PMID 38514190
  • Costamagna G, Bonato S, Corti S, Meneri M. Advancing Stroke Research on Cerebral Thrombi with Omic Technologies. Int J Mol Sci. 2023 Feb 8;24(4):3419. doi: 10.3390/ijms24043419. PMID 36834829
  • Staessens S, Fitzgerald S, Andersson T, Clarencon F, Denorme F, Gounis MJ, Hacke W, Liebeskind DS, Szikora I, van Es A, Brinjikji W, Doyle KM, De Meyer SF. Histological stroke clot analysis after thrombectomy: Technical aspects and recommendations. Int J Stroke. 2020 Jul;15(5):467-476. doi: 10.1177/1747493019884527. Epub 2019 Nov 3. PMID 31679478

Identifiers

NCT: NCT06963489 · 202543

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗