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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05933317
Recruitment Status : Recruiting
First Posted : July 6, 2023
Last Update Posted : July 6, 2023
Sponsor:
Information provided by (Responsible Party):
Tao Ouyang, Beijing Chao Yang Hospital

Study Description
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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.

Condition or disease Intervention/treatment
Pulmonary Function Diagnostic Test: Functional lung MRI

Study Design
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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Long-term Follow-up Study of Pulmonary Function Changes Using Phase-resolved Functional Lung MRI in Patients With COVID-19
Actual Study Start Date : January 1, 2023
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Diagnostic Test: Functional lung MRI
    Functional lung MRI

Outcome Measures
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Primary Outcome Measures :
  1. QDP, VDP [ Time Frame: 6 months ]
    perfusion defect percentage, ventilation defect percentage


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Inpatients and outpatients with COVID-19
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05933317


Contacts
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Contact: Tao Ouyang, Dr. +86 18720931226 ouyt1996@163.com

Locations
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China, Beijing
Beijing Chaoyang Hospital Recruiting
Beijing, Beijing, China, 100020
Contact: Tao Ouyang, Dr.    +86 18720931226    ouyt1996@163.com   
Sponsors and Collaborators
Beijing Chao Yang Hospital
Investigators
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Study Chair: Tao Ouyang, Dr. Beijing Chao Yang Hospital
More Information
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Responsible Party: Tao Ouyang, Beijing Chao Yang Hospital
ClinicalTrials.gov Identifier: NCT05933317    
Other Study ID Numbers: 202212301
First Posted: July 6, 2023    Key Record Dates
Last Update Posted: July 6, 2023
Last Verified: July 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No