Algorithms to Diagnose Pulmonary Arterial Hypertension

• Conditions: Pulmonary Arterial Hypertension
• Interventions: Other: calculated radscore

• Registration Number: NCT05417373
• Lead Sponsor: RenJi Hospital

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.

Study Timeline

• Study Start: 2019-01-17
• Status Verified: 2022-03
• Study First Submitted: 2022-06-06
• Study First Submitted QC: 2022-06-09
• Last Update Submitted: 2022-06-09
• Study First Posted: 2022-06-14
• Last Update Posted: 2022-06-14
• Primary Completion: 2022-12-01
• Study Completion: 2023-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 250

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
The validation cohort	calculated radscore	The validation cohort was composed of patients are suspected as PAH by echocardiography in 2021.5-2021.12 or suspected patients are form other medical institutions.

Primary Outcome Measures

Name	Time	Method
DIAGONOSIS	1 year	The patient is diagnosed PAH or not by right heart catheter

Trial Locations

Locations (1)

Renji Hospital; 🇨🇳 Shanghai, China