The Correlation and Mechanistic Study of GGCX Gene With Prognosis in Acute Ischemic Stroke

November 25, 2025 updated by: Xia Zhang, Peking University Aerospace Center Hospital

Study Protocol on the Correlation and Mechanistic Study of GGCX Gene With Prognosis in Acute Ischemic Stroke

This observational study aims to investigate the impact of GGCX gene mutations and GGCX levels on stroke prognosis in patients with ischemic stroke, as well as their correlation. The main issues are:

What is the relationship and potential mechanism between GGCX gene mutations and their expression levels and the composite prognosis of recurrence, death, and bleeding events in patients with ischemic stroke? Collect blood samples from enrolled ischemic stroke patients for genetic testing, and conduct follow-up visits at 3, 6, and 12 months after discharge to evaluate clinical prognosis outcomes. This will answer questions about the relationship and mechanism between GGCX gene and patient prognosis.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijing, China
        • Peking University Aerospace Center Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

This study will be conducted in six hospitals (centers) across the country, namely Xi'an Jiaotong University First Affiliated Hospital, Shandong Weifang Second People's Hospital, Shandong Linshu People's Hospital, Hunan Second People's Hospital (Hunan Brain Hospital), and Nantong First People's Hospital.

Description

  • Inclusion Criteria

    (1) Inclusion Criteria for Acute Ischemic Stroke Patients:

    1. Aged between 18 and 85 years.
    2. Diagnosed with ischemic stroke (in accordance with the "Chinese Guidelines for Diagnosis and Treatment of Acute Ischemic Stroke 2023," including TOAST etiological/pathogenic subtypes: large-artery atherosclerosis (LAA), cardioembolism (CE), small-artery occlusion (SAO), stroke of other determined etiology (SOE), and stroke of undetermined etiology (SUE)).
    3. Acute onset, with symptoms occurring within 72 hours and being the first episode.
    4. Voluntary participation with signed informed consent.

    (2) Inclusion Criteria for Healthy Controls: 1) Healthy control population matched for age, gender, and risk factors (including personal and family history).

  • Exclusion Criteria

    (1) Exclusion Criteria for Healthy Controls:

    1. Patients with cerebrovascular diseases occurring within 72 hours.
    2. Pregnant or lactating patients.

    (2) Exclusion Criteria for Acute Ischemic Stroke Patients:

    1. Other types of stroke, including hemorrhagic stroke, mixed stroke, and tumor-related stroke patients.
    2. Patients with coagulation disorders or other hematologic diseases.
    3. Patients with severe cardiovascular, pulmonary, or hepatic diseases.
    4. Renal dysfunction.
    5. Cancer patients.
    6. Patients with active gastric ulcers or gastric bleeding.
    7. Pregnant or lactating patients.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Acute Ischemic Stroke Group
These subjects were acute ischemic stroke patients who had been followed up for 3-12 months after discharge.
Combination product: Usually, all enrolled patients with acute ischemic stroke will receive routine medication and/or surgical treatment according to clinical diagnosis and treatment protocols.
The conventional drug therapy includes anticoagulant, antiplatelet, antihypertensive and other drugs. The surgical therapy includes AIS intravenous thrombolysis or endovascular therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the recurrence, death, and bleeding events of stroke in the research subjects
Time Frame: Follow up will be conducted at 3 months, 6 months, and 12 months after the patient's discharge, and the main outcome events mentioned above will be evaluated.
Including recurrent ischemic stroke events; Death events include hemorrhagic death, vascular death, and acute myocardial infarction events; Intracranial or other bleeding events (refer to the International Classification of Bleeding Events ICD-10 code).
Follow up will be conducted at 3 months, 6 months, and 12 months after the patient's discharge, and the main outcome events mentioned above will be evaluated.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University Aerospace Center Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 25, 2026

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

February 28, 2028

Study Registration Dates

First Submitted

November 25, 2025

First Submitted That Met QC Criteria

November 25, 2025

First Posted (Actual)

December 8, 2025

Study Record Updates

Last Update Posted (Actual)

December 8, 2025

Last Update Submitted That Met QC Criteria

November 25, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025017
  • 2024PSPT0905100 (Other Grant/Funding Number: NHC-Million Disability Reduction Expert Committee)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

IPD will decide whether to share based on laws and regulations and the management measures of the Clinical Trial Ethics Committee.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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