Clinical Trial on Cerebrovascular Disease - Clinical Trials Registry

Study Overview

Status

Recruiting

Conditions

Cerebrovascular Disease

Detailed Description

Cerebrovascular diseases are major diseases that pose a serious threat to human health and life, and have become the leading cause of death from disease among Chinese residents. Despite the best medical or surgical treatment options, many patients still suffer from functional disabilities, imposing a heavy burden on families and society. Identifying the complex and delicate changes in brain neural activity, blood flow, oxygenation, and metabolism following the occurrence of cerebrovascular diseases can not only explore the potential mechanisms underlying poor functional prognosis, but also provide a scientific basis for targeted treatment strategies. This study is a consecutive, multicenter, prospective registration study that recruits approximately 800 patients with cerebrovascular diseases (both hemorrhagic and ischemic stroke) aged 18-80 years within 7 days of onset. The study collects baseline information and imaging data including head CT, MRI, TCD, fNIRS, and ophthalmic testing. The primary endpoint event was functional outcome 3 months (mRS score). Secondary outcomes were in-hospital complications (including stroke progression, recurrence, and mortality), cognitive disorder, functional outcomes, recurrent stroke, new vascular events, and all-cause death at 3, 6 and 12 months .

Study Type

Observational

Enrollment (Estimated)

800

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

Name: zixiao Li, PhD
Phone Number: 00861067013383
Email: lizixiao2008@hotmail.com

Study Contact Backup

Name: WENJIE WANG, PhD
Phone Number: 18843113250
Email: wangwenjie1129@163.com

Study Locations

China
- Beijing
  - Beijing, Beijing, China, 100070
    - Recruiting
    - Beijing Tiantan Hospital
    - Contact:
      
      wenjie wang
      
      Phone Number: 18843113250

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

Patients aged 18-80 years old with acute cerebrovascular disease (hemorrhagic or ischemic stroke) within 7 days of onset； healthy adults.

Description

Inclusion Criteria:

Age between 18 and 80 years old;
Onset of symptoms within 7 days;
Clinical diagnosis of cerebrovascular disease (ischemic stroke or hemorrhagic stroke) confirmed by head imaging (CT or MRI);
Signed informed consent form.

Exclusion Criteria:

Diagnosed with non-cerebrovascular diseases (such as central nervous system infections, epilepsy, and metabolic encephalopathy);
Patients with contraindications to multimodal CT or MRI, functional near-infrared imaging, or those who cannot cooperate to complete the relevant examinations;
Patients with a life expectancy of less than 3 months or those who cannot complete the study follow-up due to other reasons.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of unfavorable functional outcome Time Frame: 3 month after enrollment	Unfavorable functional outcome is defined as mRS Score 2-5. mRS is an efficient, reliable and simple scale to assess the recovery of neurological function and disability after stroke. The high score indicates the poor neurological recovery. The minimum score (0) means no symptoms at all. The maximum (6) means death.	3 month after enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of in-hospital complications Time Frame: duration of hospital stay（about 1 week）	In-hospital complications (including stroke progression, recurrence, and mortality).	duration of hospital stay（about 1 week）
The incidence of unfavorable functional outcome Time Frame: 6 and 12 months after enrollment	Unfavorable functional outcome is defined as the modified Rankin Scale (mRS) Score 2-5. mRS is an efficient, reliable and simple scale to assess the recovery of neurological function and disability after stroke. The high score indicates the poor neurological recovery. The minimum score (0) means no symptoms at all. The maximum (6) means death.	6 and 12 months after enrollment
The incidence of new vascular events Time Frame: 3, 6 and 12 months after enrollment	Including ischemic stroke, hemorrhagic stroke, myocardial infarction or vascular death.	3, 6 and 12 months after enrollment
The incidence of recurrent stroke Time Frame: 3, 6 and 12 months after enrollment	Stroke recurrence is defined as a new focal neurological impairment that was confirmed by neuroimaging, including both ischemic stroke and hemorrhagic stroke.	3, 6 and 12 months after enrollment
The incidence of all-cause death Time Frame: 3, 6 and 12 months after enrollment	An all-cause death is defined as a death from any cause.	3, 6 and 12 months after enrollment
The incidence of Cognitive impairment Time Frame: 3, 6 and 12 months after enrollment	Cognitive impairment is assessed using the MMSE and MOCA scales, with scores below 27 on the MMSE or below 26 on the MOCA indicating the presence of cognitive impairment.	3, 6 and 12 months after enrollment

Collaborators and Investigators

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

Sponsor

Beijing Tiantan 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 (Actual)

January 1, 2025

Primary Completion (Estimated)

September 30, 2027

Study Completion (Estimated)

September 30, 2027

Study Registration Dates

First Submitted

November 20, 2024

First Submitted That Met QC Criteria

April 6, 2025

First Posted (Actual)

April 13, 2025

Study Record Updates

Last Update Posted (Actual)