a Cohort Study of Ischemic Cerebrovascular Disease

June 27, 2023 updated by: Xiangya Hospital of Central South University

a Prospective, Multicenter Cohort Study of Ischemic Cerebrovascular Disease

This study aims to establish a multicenter, large-scale, prospective cohort of patients with ischemic stroke. Various biological samples such as blood, feces, and urine are collected to identify biomarkers associated with ischemic stroke. By integrating demographic information, clinical indicators, imaging parameters, and biomarker parameters, the study aims to develop risk assessment, early warning, and prognosis prediction models. Additionally, the study aims to identify key genes and explore relevant signaling pathways related to ischemic stroke.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

5000

Contacts and Locations

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

Study Locations

  • China
      • Hunan, China, 410008
        • Recruiting
        • Xiangya Hospital, Central South University
        • Contact:

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

Non-Probability Sample

Study Population

Continuously enroll hospitalized patients who meet the inclusion criteria

Description

Inclusion Criteria:

  1. Clinical diagnosis of ischemic stroke.
  2. Age ≥ 18 years.
  3. Signed informed consent form.

Exclusion Criteria:

  1. Patients with moderate to severe mental disorders or dementia who cannot cooperate to complete the informed consent and follow-up procedures.
  2. Patients with neurological functional impairment caused by conditions such as migraine aura, epilepsy, or other non-ischemic strokes.
  3. Agitated patients who cannot cooperate with imaging examinations.
  4. Pregnant or lactating patients, as well as those planning to become pregnant within 90 days.
  5. Patients with concurrent malignant tumors or severe systemic diseases with an expected survival period of less than 90 days.
  6. Patients who have participated in other clinical studies within 30 days prior to enrollment or are currently participating in other interventional clinical studies.

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
those with favorable prognosis
Other: Intravenous thrombolysis
Intravenous thrombolysis with alteplase within the time window of stroke onset in stroke patients
those with unfavorable prognosis
Other: Intravenous thrombolysis
Intravenous thrombolysis with alteplase within the time window of stroke onset in stroke patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cerebrovascular events
Time Frame: 3 months of onset in patients
Cerebrovascular events, including ischemic stroke, transient ischemic attack, cerebral hemorrhage, subarachnoid hemorrhage
3 months of onset in patients
mRS scores
Time Frame: 3 months of onset in patients
Assessing patients' neurological functional impairment status using the mRS score
3 months of onset in patients

Collaborators and Investigators

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

Sponsor

Xiangya Hospital of Central South University

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 (Actual)

November 1, 2022

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2027

Study Registration Dates

First Submitted

June 19, 2023

First Submitted That Met QC Criteria

June 27, 2023

First Posted (Actual)

June 28, 2023

Study Record Updates

Last Update Posted (Actual)

June 28, 2023

Last Update Submitted That Met QC Criteria

June 27, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202304068

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Privacy and Confidentiality: Sharing IPD may raise concerns regarding the privacy and confidentiality of the participants. Protecting the personal information and identities of the participants is a priority, and sharing IPD may involve potential risks in this regard.

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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