Pulmonary Infection After Ischemic Stroke | NCT05923034

Studies
Pulmonary Infection After Ischemic Stroke

NCT05923034

Sponsor

Capital Medical University

Status

Unknown status

Last Update Posted

Jun 28, 2023Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

Had a Computed Tomography Scan of the Chest Within 24 Hours After Stroke Onset

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2022Actual

Primary Completion Date

Jan 20, 2023Actual

Completion Date

Jul 20, 2023Estimated

First Submitted Date

Jun 20, 2023

First Submission Date that Met QC Criteria

Jun 20, 2023

First Posted Date

Jun 28, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 20, 2023

Last Update Posted Date

Jun 28, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ji Xunming,MD,PhD, Principal Investigator, Capital Medical UniversityPrincipal Investigator

Lead Sponsor

Capital Medical UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To assess the frequency of signs of pulmonary infection on a chest CT and development of clinical diagnose of poststroke pneumonia，and its effect on functional outcome in patients with acute ischemic stroke.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Label	Type	Description	Intervention Names
had a computed tomography scan of the chest within 24 hours after stroke onset

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
With radiological signs of pulmonary infection		24 hours

Secondary Outcomes

Measure	Description	Time Frame
development of clinical poststroke pneumonia		2 weeks or at discharge
modified Rankin Scale		90 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Have a computed tomography scan of the chest within 24 hours after stroke onset

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

had a computed tomography scan of the chest within 24 hours after stroke onset

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Xunming Ji, MD	Contact	010-83199439		jixm@ccmu.edu.cn
Nan Yang, MM	Contact			384487208@qq.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Suzhou Municipal Hospital	Recruiting	Suzhou	Anhui		China