Algorithms to Diagnose Pulmonary Arterial Hypertension

NCT05417373 | Unknown

• 1 other identifier: diagnosis of PAH
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Arterial Hypertension

Keywords

Pulmonary Arterial Hypertension; Diagnosis Model; Prediction Algorithm

Outcome Measures

Primary Outcomes (1)

• DIAGONOSIS

  The patient is diagnosed PAH or not by right heart catheter

  1 year

Study Arms (2)

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

Interventions

calculated radscore OTHER

The development cohort is case\_control research. The validation cohort is prospective study to test the accuracy of calculated radscore based on diagonisis model.

The validation cohort

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Chest CT examination and cardiac ultrasound examination were performed within 3 months before and after right heart catheterization;
• 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;
• sPAP \> 36mmHg (measured by echocardiography) was collected in validation corhort.

You may not qualify if:

• 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.

Sponsors & Collaborators

• RenJi Hospital: lead
• Shanghai Zhongshan Hospital: collaborator
• The First Affiliated Hospital with Nanjing Medical University: collaborator
• Xinqiao Hospital of Chongqing: collaborator
• Shanghai Pulmonary Hospital, Shanghai, China: collaborator

Study Sites (1)

Renji Hospital

Shanghai, 200127, China

RECRUITING

Related Publications (1)

• Wan C, Chen M, Tong J, Wang A, Ruan B, Shen J. Prognostic effect of left ventricular-pulmonary arterial coupling indicator in pulmonary arterial hypertension. Int J Cardiol. 2025 Sep 1;434:133347. doi: 10.1016/j.ijcard.2025.133347. Epub 2025 May 1.

  PMID: 40318737 DERIVED

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jieyan Shen, PhD

  Shanghai Jiao Tong University School of Medicine Affiliated Renji Hospital

  STUDY CHAIR

Central Study Contacts

Jieyan Shen, PhD

CONTACT

13701864819; shenjieyan@renji.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2022
• First Posted: June 14, 2022
• Study Start: January 17, 2019
• Primary Completion: December 1, 2022
• Study Completion: June 1, 2023
• Last Updated: June 14, 2022

Record last verified: 2022-03

Locations

CN (1)