AzTrials
AzTrials

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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

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
Are there results?
Not yet: the study is under way

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.

Zhiyuan Feng, MD contact

86+15801290121

fzyhhz1996@gmail.com

5 sites in 1 country

China5 sites, 5 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

    Recruiting

  • The First Affiliated Hospital of Shihezi University

    Wuhu, Anhui

    Jie Xu, MD; PhD, +86 13910596415

    Not yet recruiting

Other trials in China

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:

  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
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.

  1. Number of patients with futile recanalization

    mRS score ≥3 at 3 months

    Measured: From enrollment to 3 month follow-up

Secondary outcomes (3)

  1. Number of patients with specific stroke etiologies

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

    Measured: Baseline

  2. 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:

    1. symptomatic intracranial hemorrhage (sICH) and asymptomatic intracranial hemorrhage (aICH)
    2. different extent: HI1, HI2, PH1, PH2

    Measured: 7 days within stroke onset

  3. 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.

  1. First posted9 May 2025
  2. Study start27 Apr 2025
  3. Primary completion29 Feb 2028 (estimated)
  4. Study completion29 Feb 2028 (estimated)

Resources

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)
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 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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/jnis-2023-021365.

    PubMed 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.

    PubMed 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.

    PubMed 31679478

  • 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.

    PubMed 34517770

  • 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.

    PubMed 35241632

  • 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.

    PubMed 36477996

  • Feng 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

Questions about this trial

What is this clinical trial studying?

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.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 11 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Zhiyuan Feng, MD (86+15801290121, fzyhhz1996@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of patients with futile recanalization (time frame: From enrollment to 3 month follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06963489, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2025; AzTrials last refreshed its copy on 26 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in