Clinical trial NCT05417373: Algorithms to Diagnose Pulmonary Arterial Hypertension
Official title: Development and Validation of a Radiomics-based Diagnosis Model for Pulmonary Arterial Hypertension
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pulmonary Arterial Hypertension
Keywords: Pulmonary Arterial Hypertension
Diagnosis Model
Prediction Algorithm
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
Collaborators: name: Shanghai Zhongshan Hospital
name: The First Affiliated Hospital with Nanjing Medical University
name: Xinqiao Hospital of Chongqing
name: Shanghai Pulmonary Hospital, Shanghai, China
First posted: 2022-06-14
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The development cohort is case_control research, composed of patients diagnosed with PAH and healthy control group from 2018.10 to now in RenjiH and Jiangsu Province Hospital.

The validation cohort is prospective study to test the accuracy of diagonisis model, composed of patients are suspected as PAH or healthy volunteer by echocardiography form other medical institutions.

Brief summary: The investigators intend to evalute the value of radiomics signature of pulmonary vessels from chest computed tomography (CT) for dianosis and prognosis of pulmonary arterial hypertension.

Detailed description: Pulmonary arterial hypertension (PAH) is a heterogeneous disorder composed of varying pathobiology that may involve multiple clinical conditions. Computed tomography (CT) is a minimally invasive imaging technique capable of providing both high contrast and high resolution detail of the lungs and arteries. Application of radiomics as prognosis and diagnosis tools could quantifies high-dimensional features from CT data to investigate vescualr heterogeneity.Development and validation of PAH diagnosis Algorithms based on radiomics may serve as a complementary readout to current CT-based metrics and provide valuable evidence to make the treatment management decision in early PAH.

Eligibility criteria: Inclusion Criteria:

1. Chest CT examination and cardiac ultrasound examination were performed within 3 months before and after right heart catheterization;
2. mPAP \> 25mmHg and PVR\< 3woods (measured by right heart catheter) and pulmonary vascular resistance was collected as PAH group whereas Healthy Volunteers as non-PAH control group in developement corhort;
3. sPAP \> 36mmHg (measured by echocardiography) was collected in validation corhort.

Exclusion Criteria:

1.Cancer; 2. The quality of chest CT and cardiac ultrasound images is poor; 3.Pulmonary vascular segmentation is affected by thoracic organ displacement or pulmonary vascular complete occlusion due to diseases ,such as spinal deformity.

Primary outcomes:
measure: DIAGONOSIS
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital
Study officials:
affiliation: Shanghai Jiao Tong University School of Medicine Affiliated Renji Hospital
name: Jieyan Shen, PhD
role: STUDY_CHAIR
References: