Study on the Accuracy of Determining the Responsible Vessel in Medium Vessel Occlusive Stroke Based on Multi-type CT Evaluation

To evaluate the accuracy of diagnosing the qualifying artery in patients with medium vessel occlusion stroke based on multimodal CT

Study Overview

• Status: Recruiting
• Conditions: Stroke

• Study Type: Observational
• Enrollment (Estimated): 622

Contacts and Locations

• Study Contact: Name: Shujuan Meng, MD; Phone Number: 01083198082; Email: 1026012717@qq.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100053
      • Recruiting
      • Xuanwu Hospital Capital Medical University
      • Contact: Shujuan Meng, MD; Phone Number: 01083198082; Email: 1026012717@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

According to previous literature reports, the prevalence of MeVO stroke accounts for 18% of ischemic stroke. It is estimated that the sensitivity of NCCT + CTA in diagnosing MeVO is 74%. Based on multimodal CT, the sensitivity for diagnosing moderate vascular occlusive stroke can be increased by 15%, reaching 89%. The test level is bilateral 0.05, and the confidence level 1 - β = 0.8. Then, at least 622 research subjects are required. Among them, the number of patients with MeVO, N1 = 622 * 0.18 = 112 cases.

Description

Inclusion Criteria:

• Patients with acute ischemic stroke, without restrictions on gender
• Age ≥ 18 years old
• The time from onset to treatment is within 24 hours (the onset time is defined as the "last-well-time", and the treatment plan is determined according to the patient's wishes and local clinical experience)
• Before the treatment, CT, CTA and CTP examinations were conducted, and the relevant clinical data were complete.

Exclusion Criteria:

• Patients with acute intracranial hemorrhage
• Patients whose CTP original images cannot be processed by the CTP post-processing software
• Patients for whom the DICOM format image data of CT, CTP original images and MRI images cannot be obtained, or whose image quality is poor due to various reasons

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
NCCT+CTA group; The attending physicians of neurology (with more than 5 years of experience in neuroimaging interpretation and not relevant to this study), without knowing the final radiological report, DSA, MRI results and clinical manifestations, only used baseline non-contrast CT (NCCT) and CTA to determine whether the included cases had moderate vascular occlusion. And record the qualifying artery
NCCT+CTA+CTP group; The attending physicians of neurology (with more than 5 years of experience in neuroimaging interpretation and not relevant to this study), without knowing the final radiological report, DSA, MRI results and clinical manifestations, only used baseline non-contrast CT (NCCT) , CTA and CTP to determine whether the included cases had moderate vascular occlusion. And record the qualifying artery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The difference in accuracy between the evaluation of MeVO stroke using multimode CT and that using NCCT+CTA	The difference in accuracy between the evaluation of MeVO stroke using multimode CT and that using NCCT+CTA	at baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The time required by the reader to identify the qualifying artery before and after using CTP	The time required by the reader to identify the qualifying artery before and after using CTP	at baseline
The consistency between the core infarction volume evaluated based on CTP and the final infarction volume obtained from MRI examination within 7 days after the onset	The consistency between the core infarction volume evaluated based on CTP and the final infarction volume obtained from MRI examination within 7 days after the onset	7 days after the onset

Collaborators and Investigators

• Sponsor: Xuanwu Hospital, Beijing
• Collaborators: Beijing Hospitals Authority

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2025
• Primary Completion (Estimated): March 13, 2026
• Study Completion (Estimated): March 13, 2026

Study Registration Dates

• First Submitted: January 9, 2026
• First Submitted That Met QC Criteria: January 9, 2026
• First Posted (Estimated): January 16, 2026

Study Record Updates

• Last Update Posted (Estimated): January 16, 2026
• Last Update Submitted That Met QC Criteria: January 9, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Multimodal CT; CTP; medium vessel occlusion
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke
• Other Study ID Numbers: XMEC-2025-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No