Algorithms to Diagnose Pulmonary Arterial Hypertension

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational [Patient Registry]
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05417373
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

RenJi Hospital
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Jieyan Shen, PhD
Principal Investigator Affiliation Shanghai Jiao Tong University School of Medicine Affiliated Renji Hospital
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Pulmonary Arterial Hypertension
Additional Details

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.

Arms & Interventions

Arms

: 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.

Interventions

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.

Contact a Trial Team

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International Sites

Renji Hospital, Shanghai, China

Status

Recruiting

Address

Renji Hospital

Shanghai, , 200127

Site Contact

Binaqian Ruan, postgraduate

907945323@qq.com

+8613616692589

For more information, please contact PHA at Research@PHAssociation.org and refer to the terms of service below.

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