Algorithms to Diagnose Pulmonary Arterial Hypertension

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

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.

Study Overview

• Status: Recruiting
• Conditions: Pulmonary Arterial Hypertension
• Intervention / Treatment: Other: calculated radscore

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 Type: Observational
• Enrollment (Anticipated): 250

Contacts and Locations

• Study Contact: Name: Jieyan Shen, PhD; Phone Number: 13701864819; Email: shenjieyan@renji.com

Study Locations

• China
  • Shanghai, China, 200127
    • Recruiting
    • Renji hospital
    • Contact: Binaqian Ruan, postgraduate; Phone Number: +8613616692589; Email: 907945323@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
The development cohort; The development cohort was composed of patients diagnosed with PAH and healthy control group from 2019.1-2021.5 in RenjiH.
The validation cohort; 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
DIAGONOSIS	The patient is diagnosed PAH or not by right heart catheter	1 year

Collaborators and Investigators

• Sponsor: RenJi Hospital
• Collaborators: The First Affiliated Hospital with Nanjing Medical University; Shanghai Zhongshan Hospital; Shanghai Pulmonary Hospital, Shanghai, China; Xinqiao Hospital of Chongqing

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2019
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: June 6, 2022
• First Submitted That Met QC Criteria: June 9, 2022
• First Posted (Actual): June 14, 2022

Study Record Updates

• Last Update Posted (Actual): June 14, 2022
• Last Update Submitted That Met QC Criteria: June 9, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Pulmonary Arterial Hypertension; Diagnosis Model; Prediction Algorithm
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension, Pulmonary; Hypertension; Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension
• Other Study ID Numbers: diagnosis of PAH

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No