- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03883048
Idiopathic Bronchiectasis and Pulmonary Hypertension
The Optimal Noninvasive Indicator for Identify Pulmonary Hypertension Will be Determined. Difference of Some Indexes Between Bronchiectasis With Pulmonary Hypertension and Bronchiectasis Without Pulmonary Hypertension.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Between April 2011 and December 2019, the data of idiopathic bronchiectasis patients were analyzed to determine the optimal noninvasive tool to identify PH. Based on the patients who received RHC examination, Spearman correlation was used to assess the correlation between mean pulmonary arterial pressure (mPAP) and systolic pulmonary arterial pressure (sPAP) measured by RHC and other noninvasive indicators (estimated PASP assessed by echocardiography, main pulmonary artery (MPA) diameter and MPA/ ascending aorta (AA) ratio on chest HRCT scan), in order to screening out the optimal indicator to identify PH. Then the sensitivity and specificity of the indicator was calculated through the receiving operating characteristics (ROC) analysis and the critical point of the indicator was determined by Youden index.
Based on critical point of that indicator, a large sample study from hospital medical database for patients with idiopathic bronchiectasis in Shanghai Pulmonary Hospital (Shanghai, China) between May 2013 and December 2019 was conducted. The following data were collected: demographic information (i.e., age and sex); clinical characteristics (age of symptom onset, duration after bronchiectasis diagnosis, and body mass index [BMI]); radiological presentation (the type of bronchiectasis, and involved lung lobe and segment); pulmonary function (forced vital capacity [FVC], forced expiratory volume in 1 second [FEV1], and FEV1/FVC); N-terminal pro brain natriuretic peptide (N-proBNP); arterial blood gas and microbiological detection in respiratory tract specimen (sputum or bronchoalveolar lavage fluid). The number of hospitalizations and emergency visits in past 12 months before the first hospitalization were collected based on patient's medical records. Patients were followed up by telephone until December 2021.
The idiopathic patients who received echocardiography examination were divided into two groups. The risk factors of PH associated with idiopathic bronchiectasis and the effect of PH on the prognosis of patients with bronchiectasis were analyzed through statistical method.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Shanghai
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Shanghai, Shanghai, China, 200000
- Shanghai Pulmonary Hospital, Tongji University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
- Between April 2011 and December 2019, patients with bronchiectasis received right heart catheterization examination.
- The patients with idiopathic bronchiectasis received echocardiography from May 2013 to Dec 2019.
Description
Inclusion Criteria:
- Age ≥ 18;
- Patients with typical bronchiectasis on CHEST HRCT;
- Patients with bronchiectasis without known cause.
Exclusion Criteria:
- Patients with allergic bronchopulmonary aspergillosis (ABPA).
- Patients with bronchiectasis combined with pulmonary tuberculosis and non-tuberculous mycobacterium tuberculosis.
- Patients with bronchiectasis due to genetic factors.
- Bronchiectasis patients with connective tissue diseases.
- Patients with bronchiectasis with interstitial lung disease.
- Combined with pulmonary embolism, pneumothorax, mediastinal emphysema and lung tumor.
- Patients with bronchiectasis associated with chronic obstructive pulmonary and bronchial asthma.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The optimal noninvasive indicator for identify pulmonary hypertension
Time Frame: April/01/2011-Decemeber/31/2019
|
Based on the patients who received right heart catheterization examination, the optimal noninvasive indicator for identify PH was determined
|
April/01/2011-Decemeber/31/2019
|
Differance of some indexes between Bronchiectasis with pulmonary hypertension and Bronchiectasis without pulmonary hypertension
Time Frame: May/01/2013-Decemeber/31/2019
|
Differance of some indexes (ie.
course, clinical presentation, type and scope of bronchiolitis, lung function, pseudomonas aeruginosa in respiratory tract specimen and prognosis) between Bronchiectasis with pulmonary hypertension and Bronchiectasis without pulmonary hypertension
|
May/01/2013-Decemeber/31/2019
|
Collaborators and Investigators
Investigators
- Study Director: Jin-fu Mr Xu, Doctor, Shanghai Pulmonary Hospital, Shanghai, China
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018052395
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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