a Cohort Study of Ischemic Cerebrovascular Disease

NCT05922540 | Recruiting

• 1 other identifier: 202304068
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ischaemic Stroke

Outcome Measures

Primary Outcomes (2)

• Cerebrovascular events

  Cerebrovascular events, including ischemic stroke, transient ischemic attack, cerebral hemorrhage, subarachnoid hemorrhage

  3 months of onset in patients

• mRS scores

  Assessing patients' neurological functional impairment status using the mRS score

  3 months of onset in patients

Study Arms (2)

those with favorable prognosis

Other: Intravenous thrombolysis

those with unfavorable prognosis

Other: Intravenous thrombolysis

Interventions

Intravenous thrombolysis OTHER

Intravenous thrombolysis with alteplase within the time window of stroke onset in stroke patients

those with favorable prognosis; those with unfavorable prognosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Continuously enroll hospitalized patients who meet the inclusion criteria

You may qualify if:

• Clinical diagnosis of ischemic stroke.
• Age ≥ 18 years.
• Signed informed consent form.

You may not qualify if:

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

Sponsors & Collaborators

• Xiangya Hospital of Central South University: lead

Study Sites (1)

Xiangya Hospital, Central South University

Hunan, 410008, China

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2023
• First Posted: June 28, 2023
• Study Start: November 1, 2022
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2027
• Last Updated: June 28, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)