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临床试验/NCT03883048
NCT03883048已完成不适用

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.

Shanghai Pulmonary Hospital, Shanghai, China1 个研究点 分布在 1 个国家目标入组 1,606 人开始时间: 2018年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,606
试验地点
1
主要终点
The optimal noninvasive indicator for identify pulmonary hypertension

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients with typical bronchiectasis on CHEST HRCT;
  • •Patients with bronchiectasis without known cause.

排除标准

  • •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.

结局指标

主要结局

The optimal noninvasive indicator for identify pulmonary hypertension

时间窗: 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

时间窗: 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

次要结局

未报告次要终点

研究者

发起方
Shanghai Pulmonary Hospital, Shanghai, China
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jin-Fu Xu

Proffessor

Shanghai Pulmonary Hospital, Shanghai, China

研究点 (1)

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