Large Vessel OcclusionCLOMBNCT06963489
Cerebral Large Vessel Occlusion Stroke Multiomics Biosample Cohort
An observational study of Large Vessel Occlusion and Acute Ischemic Stroke, run by First Affiliated Hospital of Wannan Medical College at 5 sites in China.
Trial 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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Large Vessel Occlusion, Acute Ischemic Stroke
- What is being tested?
- Not applicable- observational study
- How many people
- 500 participants
- Where
- 5 sitesChina
- Study dates
- 27 Apr 2025to 29 Feb 2028
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: We include patients with acute large vessel occlusion ischemic stroke from at least 5 stroke centers in China.
Who may be able to join
- 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.
- For prospectively enrolled patients, informed consent for this study was signed at the time of enrollment by the patient or their family.
Who cannot join
- Patients for whom biological samples cannot be obtained;
- Patients or their family members who refuse to sign the informed consent form.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
China5 sites, 5 recruiting
- Recruiting
Baotou Central Hospital
Baotou, Inner Mongolia
Xiwa Feng, MD; PhD, +86 13347180510, 13347180510@163.com
- Recruiting
Capital medical university of Beijing Tiantan Hospital
Beijing, 100070
Zhiyuan Feng, MD, +86 15801290121, fzyhhz1996@gmail.com
- Recruiting
The First Affiliated Hospital of zhengzhou University
Henan, Zhengzhou
Linyu Wang, MD, +86 17703855777, 1109001@163.com
- Recruiting
Affiliated Hospital of Shandong University of Traditional Chinese Medicine Hospital
Jinan, Shandong
Jinping Zhang, MD, +86 18563727655, zhangjinpingdoctor@126.com
- Not yet recruiting
The First Affiliated Hospital of Shihezi University
Wuhu, Anhui
Jie Xu, MD; PhD, +86 13910596415
About this study
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).
Read the 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:
- 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
- Conditions
- Large Vessel Occlusion, Acute Ischemic Stroke
- Being tested
- Not applicable- observational study
- Keywords
- multiomics, acute ischemic stroke with large vessel occlusion
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Not applicable- observational studyOther
Intervention is not applicable
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with futile recanalization
mRS score ≥3 at 3 months
Measured: From enrollment to 3 month follow-up
Secondary outcomes (3)
Number of patients with specific stroke etiologies
Patients will be classified as Cardioembolism or Large artery atherosclerosis as a final stroke etiology.
Measured: Baseline
Number of patients with hemorrhagic transformation
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
Measured: 7 days within stroke onset
Number of patients with infarct expansion
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2025
- Study start27 Apr 2025
- Primary completion29 Feb 2028 (estimated)
- Study completion29 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Large Vessel OcclusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Wannan Medical College
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Tiantan Hospital, The First Affiliated Hospital of Zhengzhou University, Baotou Central Hospital, Affiliated Hospital of Shandong University of Traditional Chinese Medicine
- Responsible party
- Principal investigator, Jie Xu, First Affiliated Hospital of Wannan Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06963489
- Sponsor's protocol ID
- 202543
- Acronym
- CLOMB
- Status last verified
- Apr 2025
- First submitted
- 28 Apr 2025
- Last updated
- 11 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 38293908Kollikowski 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.
PubMed 31899551Strinitz 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.
PubMed 34502070Stoll 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.
PubMed 35676801Zimmermann 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.
PubMed 35107055Dargazanli 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.
PubMed 38514190Costamagna 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.
PubMed 36834829Staessens 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.
PubMed 31679478Staessens 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.
PubMed 34517770Patil 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.
PubMed 35241632Widimsky 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.
PubMed 36477996Feng Z, Yang M, Xue J, Zhang F, Ma N, Xianjun H, Zhou Z, Hao X, Jiang CC, Wang L, Guan S, Li H, Zhang J, Xu J, Wang Y. Cerebral large vessel occlusion stroke multiomics biosample cohort (CLOMB): a multicentre cohort protocol. Stroke Vasc Neurol. 2026 Aug 7:svn-2025-004729. doi: 10.1136/svn-2025-004729. Online ahead of print.
PubMed 42567544