Cerebral Large Vessel Occlusion Stroke Multiomics Biosample Cohort
NCT ID: NCT06963489
Last Updated: 2025-05-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
500 participants
OBSERVATIONAL
2025-04-27
2028-02-29
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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COHORT
OTHER
Interventions
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Not applicable- observational study
Intervention is not applicable
Eligibility Criteria
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Inclusion Criteria
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
2. Patients or their family members who refuse to sign the informed consent form.
ALL
No
Sponsors
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Beijing Tiantan Hospital
OTHER
The First Affiliated Hospital of Zhengzhou University
OTHER
Baotou Central Hospital
OTHER
Affiliated Hospital of Shandong University of Traditional Chinese Medicine
OTHER
First Affiliated Hospital of Wannan Medical College
OTHER
Responsible Party
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Jie Xu
Deputy Director
Locations
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The First Affiliated Hospital of Shihezi University
Wuhu, Anhui, China
Baotou Central Hospital
Baotou, Inner Mongolia, China
Affiliated Hospital of Shandong University of Traditional Chinese Medicine Hospital
Jinan, Shandong, China
The First Affiliated Hospital of zhengzhou University
Henan, Zhengzhou, China
Capital medical university of Beijing Tiantan Hospital
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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Jie Xu, MD; PhD
Role: primary
References
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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.
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.
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.
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.
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.
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/jnis-2023-021365.
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.
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.
Staessens S, Francois O, Brinjikji W, Doyle KM, Vanacker P, Andersson T, De Meyer SF. Studying Stroke Thrombus Composition After Thrombectomy: What Can We Learn? Stroke. 2021 Nov;52(11):3718-3727. doi: 10.1161/STROKEAHA.121.034289. Epub 2021 Sep 14.
Patil S, Darcourt J, Messina P, Bozsak F, Cognard C, Doyle K. Characterising acute ischaemic stroke thrombi: insights from histology, imaging and emerging impedance-based technologies. Stroke Vasc Neurol. 2022 Aug;7(4):353-363. doi: 10.1136/svn-2021-001038. Epub 2022 Mar 3.
Widimsky P, Snyder K, Sulzenko J, Hopkins LN, Stetkarova I. Acute ischaemic stroke: recent advances in reperfusion treatment. Eur Heart J. 2023 Apr 7;44(14):1205-1215. doi: 10.1093/eurheartj/ehac684.
Other Identifiers
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202543
Identifier Type: -
Identifier Source: org_study_id
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