NCT06963489

Brief 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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
22mo left

Started Apr 2025

Typical duration for all trials

Geographic Reach
1 country

5 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress36%
Apr 2025Feb 2028

Study Start

First participant enrolled

April 27, 2025

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

April 28, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 9, 2025

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 29, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 29, 2028

Last Updated

May 11, 2025

Status Verified

April 1, 2025

Enrollment Period

2.8 years

First QC Date

April 28, 2025

Last Update Submit

May 9, 2025

Conditions

Keywords

multiomicsacute ischemic stroke with large vessel occlusion

Outcome Measures

Primary Outcomes (1)

  • Number of patients with futile recanalization

    mRS score ≥3 at 3 months

    From enrollment to 3 month follow-up

Secondary Outcomes (3)

  • Number of patients with specific stroke etiologies

    Baseline

  • Number of patients with hemorrhagic transformation

    7 days within stroke onset

  • Number of patients with infarct expansion

    Baseline

Interventions

Intervention is not applicable

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

We include patients with acute large vessel occlusion ischemic stroke from at least 5 stroke centers in China.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

The First Affiliated Hospital of Shihezi University

Wuhu, Anhui, China

NOT YET RECRUITING

Baotou Central Hospital

Baotou, Inner Mongolia, China

RECRUITING

Affiliated Hospital of Shandong University of Traditional Chinese Medicine Hospital

Jinan, Shandong, China

RECRUITING

The First Affiliated Hospital of zhengzhou University

Henan, Zhengzhou, China

RECRUITING

Capital medical university of Beijing Tiantan Hospital

Beijing, 100070, China

RECRUITING

Related Publications (11)

  • 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: 38293908BACKGROUND
  • 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: 31899551BACKGROUND
  • 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: 34502070BACKGROUND
  • 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: 35676801BACKGROUND
  • 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: 35107055BACKGROUND
  • 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.

    PMID: 38514190BACKGROUND
  • 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: 36834829BACKGROUND
  • 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: 31679478BACKGROUND
  • 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.

    PMID: 34517770BACKGROUND
  • 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.

    PMID: 35241632BACKGROUND
  • 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.

    PMID: 36477996BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

intracranial thrombi, intracranial occluded segment blood, peripheral arterial blood, peripheral venous blood,

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Zhiyuan Feng, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy Director

Study Record Dates

First Submitted

April 28, 2025

First Posted

May 9, 2025

Study Start

April 27, 2025

Primary Completion (Estimated)

February 29, 2028

Study Completion (Estimated)

February 29, 2028

Last Updated

May 11, 2025

Record last verified: 2025-04

Locations