NCT04952883

Brief Summary

HRCT was used to evaluate pulmonary vascular remodeling in COPD. The role of H2S in pulmonary vascular remodeling in COPD was analyzed, in order to provide a basis for seeking new therapeutic targets.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

December 1, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

June 29, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 7, 2021

Completed
Last Updated

July 12, 2021

Status Verified

June 1, 2021

Enrollment Period

9 months

First QC Date

June 29, 2021

Last Update Submit

July 8, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Plasma levels of H2S and its synthase nucleic acid and pulmonary vascular remodeling indexes on HRCT in COPD patients

    1 year

Secondary Outcomes (1)

  • Relationship between plasma H2S and its synthase nucleic acid levels and pulmonary vascular remodeling indexes on HRCT in patients with COPD

    1 year

Study Arms (1)

COPD patients

The COPD questionnaire was conducted to collect the data of lung function, echocardiography and blood gas analysis, and the pulmonary vessels of HRCT were determined. Blood samples were collected for H2S-related indicators detection.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Outpatient with stable chronic obstructive pulmonary disease

You may qualify if:

  • Patients meet the GOLD 2016 guidelines for diagnostic criteria of COPD: dyspnea, chronic cough and/or sputum symptoms, exposure to risk factors, and pulmonary function after inhalation of bronchodilator with forced expiratory volume (FEV1)/forced vital capacity (FVC) \< 70%.

You may not qualify if:

  • \- 1. Other lung diseases such as pneumonia, lung cancer, tuberculosis, pulmonary embolism, heart diseases such as heart failure, ventricular septal defect, patent ductus arteriosus, thoracic deformity and pleural diseases.
  • \. Patients who are unable to understand and/or complete questionnaire.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University Third Hospital

Beijing, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Plasma and RNA

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Yahong Chen, PHD

    Peking University Third Hospital

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

June 29, 2021

First Posted

July 7, 2021

Study Start

December 1, 2016

Primary Completion

September 1, 2017

Study Completion

December 1, 2017

Last Updated

July 12, 2021

Record last verified: 2021-06

Locations