A Long-term Follow-up Study of Pulmonary Function Changes... | NCT05933317

Studies
A Long-term Follow-up Study of Pulmonary Function Changes Using Phase-resolved Functional Lung MRI in Patients With COVID-19

NCT05933317

Sponsor

Beijing Chao Yang Hospital

Status

Unknown status

Last Update Posted

Jul 6, 2023Actual

Enrollment

150Estimated

Phase

Not provided

Conditions

Pulmonary Function

Interventions

Functional lung MRI

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

Jul 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

Jan 1, 2023Actual

Primary Completion Date

Dec 31, 2023Estimated

Completion Date

Dec 31, 2024Estimated

First Submitted Date

Jul 5, 2023

First Submission Date that Met QC Criteria

Jul 5, 2023

First Posted Date

Jul 6, 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

Jul 5, 2023

Last Update Posted Date

Jul 6, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Tao Ouyang, Beijing Chao Yang Hospital, Beijing Chao Yang HospitalPrincipal Investigator

Lead Sponsor

Beijing Chao Yang HospitalOTHER

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

So far, the number of COVID-19 infections worldwide has exceeded 700 million. Long-term damage to the lungs is a major sequela of COVID infection. Pulmonary function testing is an important means for the evaluation of lung damage. MRI examinations with free breathing and no contrast agent can prevent patients from suffering from ionizing radiation damage caused by multiple CT examinations.

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

150Estimated

Name	Type	Description	Arm Group Labels	Other Names
Functional lung MRI	Diagnostic Test	Functional lung MRI

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
QDP, VDP	perfusion defect percentage, ventilation defect percentage	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Older than 18 years; Sign the informed consent; Patients diagnosed with COVID-19 by nucleic acid test and survived to be discharged; Complete clinical data during hospitalization.

Exclusion Criteria:

Patients with bacterial pneumonia; Patients with MRI contraindications.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Inpatients and outpatients with COVID-19

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Tao Ouyang, Dr.	Contact	+86 18720931226		ouyt1996@163.com

Overall Officials

Name	Affiliation	Role
Tao Ouyang, Dr.	Beijing Chao Yang Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Beijing Chaoyang Hospital	Recruiting	Beijing	Beijing Municipality	100020	China