NCT07347587

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
622

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 13, 2025

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 9, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 16, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 13, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 13, 2026

Completed
Last Updated

January 16, 2026

Status Verified

January 1, 2026

Enrollment Period

1 year

First QC Date

January 9, 2026

Last Update Submit

January 9, 2026

Conditions

Keywords

medium vessel occlusionMultimodal CTCTP

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • 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

    7 days after the onset

Study Arms (2)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xuanwu Hospital Capital Medical University

Beijing, Beijing Municipality, 100053, China

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Shujuan Meng, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2026

First Posted

January 16, 2026

Study Start

March 13, 2025

Primary Completion

March 13, 2026

Study Completion

March 13, 2026

Last Updated

January 16, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations