a Cohort Study of Ischemic Cerebrovascular Disease

Ischaemic Stroke Clinical Trial

Official title:

a Prospective, Multicenter Cohort Study of Ischemic Cerebrovascular Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05922540
• Other study ID #: 202304068
• Status: Recruiting
• Start date: November 1, 2022
• Est. completion date: November 1, 2027

Study information

• Verified date: June 2023
• Source: Xiangya Hospital of Central South University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: November 1, 2027
• Est. primary completion date: November 1, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cerebrovascular Disorders
• Ischaemic Stroke
• Ischemia
• Ischemic Stroke

Intervention

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

Locations

Country	Name	City	State
China	Xiangya Hospital, Central South University	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Xiangya Hospital of Central South University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cerebrovascular events	Cerebrovascular events, including ischemic stroke, transient ischemic attack, cerebral hemorrhage, subarachnoid hemorrhage	3 months of onset in patients
Primary	mRS scores	Assessing patients' neurological functional impairment status using the mRS score	3 months of onset in patients