Algorithms to Diagnose Pulmonary Arterial Hypertension

Pulmonary Arterial Hypertension Clinical Trial

Official title:

Development and Validation of a Radiomics-based Diagnosis Model for Pulmonary Arterial Hypertension

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05417373
• Other study ID #: diagnosis of PAH
• Status: Recruiting
• Start date: January 17, 2019
• Est. completion date: June 1, 2023

Study information

• Verified date: March 2022
• Source: RenJi Hospital
• Contact: Jieyan Shen, PhD
• Phone: 13701864819
• Email: shenjieyan[@]renji.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: June 1, 2023
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Familial Primary Pulmonary Hypertension
• Hypertension
• Pulmonary Arterial Hypertension

Intervention

Other:
• calculated radscore
The development cohort is case_control research. The validation cohort is prospective study to test the accuracy of calculated radscore based on diagonisis model.

Locations

Country	Name	City	State
China	Renji Hospital	Shanghai

Sponsors (5)

Lead Sponsor	Collaborator
RenJi Hospital	Shanghai Pulmonary Hospital, Shanghai, China, Shanghai Zhongshan Hospital, The First Affiliated Hospital with Nanjing Medical University, Xinqiao Hospital of Chongqing

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DIAGONOSIS	The patient is diagnosed PAH or not by right heart catheter	1 year