Idiopathic Bronchiectasis and Pulmonary Hypertension

September 29, 2023 updated by: Jin-Fu Xu, Shanghai Pulmonary Hospital, Shanghai, China

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.

Patients with idiopathic bronchiectasis who received right heart catheterization (RHC) were included to evaluate the consistency between pulmonary arterial pressure (PAP) and other noninvasive indicators (pulmonary arterial systolic pressure [PASP] calculated by echocardiography, main pulmonary artery [MPA] diameter and MPA/ascending aorta ratio on chest high-resolution computed tomography [HRCT]). Then the optimal noninvasive indicator for identify PH was determined and its critical point was obtained according to the Youden Index. Based on this, we investigate the proportion, risk factors and prognosis of PH in idiopathic bronchiectasis patients in another large-scale population.

Study Overview

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

Observational

Enrollment (Actual)

1606

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Shanghai
      • Shanghai, Shanghai, China, 200000
        • Shanghai Pulmonary Hospital, Tongji University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

  1. Between April 2011 and December 2019, patients with bronchiectasis received right heart catheterization examination.
  2. The patients with idiopathic bronchiectasis received echocardiography from May 2013 to Dec 2019.

Description

Inclusion Criteria:

  1. Age ≥ 18;
  2. Patients with typical bronchiectasis on CHEST HRCT;
  3. Patients with bronchiectasis without known cause.

Exclusion Criteria:

  1. Patients with allergic bronchopulmonary aspergillosis (ABPA).
  2. Patients with bronchiectasis combined with pulmonary tuberculosis and non-tuberculous mycobacterium tuberculosis.
  3. Patients with bronchiectasis due to genetic factors.
  4. Bronchiectasis patients with connective tissue diseases.
  5. Patients with bronchiectasis with interstitial lung disease.
  6. Combined with pulmonary embolism, pneumothorax, mediastinal emphysema and lung tumor.
  7. Patients with bronchiectasis associated with chronic obstructive pulmonary and bronchial asthma.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Jin-fu Mr Xu, Doctor, Shanghai Pulmonary Hospital, Shanghai, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2018

Primary Completion (Actual)

December 31, 2021

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

March 19, 2019

First Submitted That Met QC Criteria

March 19, 2019

First Posted (Actual)

March 20, 2019

Study Record Updates

Last Update Posted (Actual)

October 3, 2023

Last Update Submitted That Met QC Criteria

September 29, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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