BronchiectasisNCT03883048
Idiopathic Bronchiectasis and Pulmonary Hypertension
An observational study of Bronchiectasis and Pulmonary Hypertension, run by Shanghai Pulmonary Hospital, Shanghai, China at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bronchiectasis, Pulmonary Hypertension
- What is being tested?
- Observation of bronchiectasis with pulmonary hypertension
- How many people
- 1,606 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2018to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Age ≥ 18;
- Patients with typical bronchiectasis on CHEST HRCT;
- Patients with bronchiectasis without known cause.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Pulmonary Hospital, Tongji University
Shanghai, Shanghai Municipality, 200000
About this study
Official title: 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.
Read the 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.
- Conditions
- Bronchiectasis, Pulmonary Hypertension
- Being tested
- Observation of bronchiectasis with pulmonary hypertension
- Medical subject headings
- Bronchiectasis, Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observation of bronchiectasis with pulmonary hypertensionOther
What is being measured
The primary outcome is the main question the study is designed to answer.
The optimal noninvasive indicator for identify pulmonary hypertension
Based on the patients who received right heart catheterization examination, the optimal noninvasive indicator for identify PH was determined
Measured: April/01/2011-Decemeber/31/2019
Differance of some indexes between Bronchiectasis with pulmonary hypertension and Bronchiectasis without pulmonary hypertension
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
Measured: May/01/2013-Decemeber/31/2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2019
- Study start1 Jun 2018
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BronchiectasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,606 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin-Fu Xu, Shanghai Pulmonary Hospital, Shanghai, China
- Investigators
- Jin-fu Mr Xu, Doctor, Study director, Shanghai Pulmonary Hospital, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03883048
- Sponsor's protocol ID
- 2018052395
- Status last verified
- Sep 2023
- First submitted
- 19 Mar 2019
- Last updated
- 3 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT03883048
- Acronym / sponsor ID
- 2018052395
- Conditions
- Bronchiectasis, Pulmonary Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,606 participants (actual)
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, ChinaUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 20 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Age ≥ 18;
- Patients with typical bronchiectasis on CHEST HRCT;
- Patients with bronchiectasis without known cause.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observation of bronchiectasis with pulmonary hypertension | Other | – |
Primary outcome
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Bronchiectasis
RecruitingObservational study
Natural History of Bronchiectasis
Bronchiectasis, Cystic Fibrosis
Enrolling by invitationObservational study
Investigating Novel Strategies in Pediatric Immune Responses and Microbiome Environment: Comprehensive Lung Disease Investigation in Children.
Lung Diseases
Recruiting
Diagnostic Value of Oropharyngeal Suction and Effect of Respiratory Physiotherapy on the Detection of Microorganisms in the Pediatric Patient
Cystic Fibrosis (CF), Bronchiectasis, Non-Cystic Fibrosis
RecruitingPhase 3
The AIRTIVITY™ Study: A Study to Find Out Whether BI 1291583 Helps People With Bronchiectasis
Bronchiectasis
Active, not recruitingObservational study
Sleep Quality in Patients With Non-cystic Fibrosis Bronchiectasis
Bronchiectasis, Sleep-Disordered Breathing
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jin-fu Mr Xu, Doctor study director
Shanghai Pulmonary Hospital, Shanghai, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bronchiectasis and Pulmonary Hypertension, run by Shanghai Pulmonary Hospital, Shanghai, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The optimal noninvasive indicator for identify pulmonary hypertension (time frame: April/01/2011-Decemeber/31/2019). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2023.