NCT06170086

Brief Summary

Prospective identification of potential responsible blood vessels, provision of intervention targets, prevention of fatal and disabling cerebrovascular diseases, identification of early END patients, determination of clinical treatment pathways, improvement of efficacy, and improvement of prognosis

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
28mo left

Started Sep 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress54%
Sep 2023Sep 2028

Study Start

First participant enrolled

September 1, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 6, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 14, 2023

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2028

Last Updated

December 14, 2023

Status Verified

December 1, 2023

Enrollment Period

5 years

First QC Date

December 6, 2023

Last Update Submit

December 6, 2023

Conditions

Keywords

Perforating arteryAcute stroke

Outcome Measures

Primary Outcomes (3)

  • Offending vessels

    The blood vessels that cause stroke

    5 years

  • Core infarct volume

    The volume of high signal in the infarcted area on DWl or T2 FLAIR

    5 years

  • NIH Stroke Scale (NIlSS)

    The NIHSS score includes: consciousness level (consciousness level, consciousness level questioning, consciousness level instruction), gaze, field of vision, facial paralysis, upper limb movement, lower limb movement, limb ataxia, sensation, language, articulation disorders, and neglect. The scoring range is 0-42 points, with higher scores indicating more severe neurological damage

    5 years

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

A. Acute Perforating artery stroke patients within 48 hours of onset; B. Age ≥ 18 years and ≤ 80 years old; C. Have two or more vascular risk factors, including hypertension, diabetes, coronary heart disease, hyperlipidemia, smoking and obesity; D. Sign an informed consent form;

You may qualify if:

  • A. Acute Perforating artery stroke patients within 48 hours of onset; B. Age ≥ 18 years and ≤ 80 years old; C. Have two or more vascular risk factors, including hypertension, diabetes, coronary heart disease, hyperlipidemia, smoking and obesity; D. Sign an informed consent form;

You may not qualify if:

  • A. Patients with large artery stroke; B. Contraindications to magnetic resonance imaging or pregnant women; C. Other vascular lesions, such as aneurysms, vascular dissection, vasculitis, and brain tumors;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy Director of Department of Radiology

Study Record Dates

First Submitted

December 6, 2023

First Posted

December 14, 2023

Study Start

September 1, 2023

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

September 1, 2028

Last Updated

December 14, 2023

Record last verified: 2023-12

Locations