Artificial Intelligence-assisted Evaluation of Pulmonary HYpertension (AIPHY)

Chinese Pulmonary Vascular Disease Research Group

Status: Enrolling

Conditions: Pulmonary Hypertension; Pulmonary Arterial Hypertension

Treatments: Diagnostic Test: Right heart catheterization

Study type: Observational

Funder types: Other

Identifiers

NCT05566002

AIPHY Project

Details and patient eligibility

About

Pulmonary hypertension represents a challenging and heterogeneous condition that is associated with high mortality and morbidity if left untreated. Artificial intelligence is used to study and develop theories and methods that simulate and extend human intelligence, which is being applied in fields related to cardiovascular diseases. The study intends to combine multimodal clinical data of patients who undergo right heart catheterization at Fuwai Hospital with artificial intelligence techniques to create programs that can screen and diagnose pulmonary hypertension.

Full description

Patients with pulmonary hypertension (PH) represent a challenging and heterogeneous cohort with high morbidity and mortality if left untreated. To make a definitive diagnosis of PH, one needs to conduct an invasive right heart catheterization (RHC) in order to assess the mean pulmonary artery pressure (mPAP). As PH occurs sporadically in various medical conditions, including connective tissue disease, and congenital heart disease, and presenting symptoms are non-specific, there is a need to raise the suspicion of PH early in the community. For this reason, noninvasive tools that are widely available for upfront screening would be ideal to enable timely diagnosis of PH. Transthoracic echocardiography has emerged as the mainstay for screening of PH, yet the sensitivity and specificity of this approach remain limited even in experienced hands. As high-throughput technologies advance and access to PH big data improve, it will be critical to prudently select artificial intelligence approaches for data analysis, visualization, and interpretation. By combining the multimodal clinical data (such as indicators from chest X-ray, electrocardiography, and echocardiography), this study aims to develop artificial intelligence-assisted programs to assist the screening and diagnosis of PH, and to evaluate its diagnostic accuracy for PH as compared with RHC, and to estimate whether this approach outperforms the conventional echocardiographic method.

Enrollment: 2,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age ≥18 years old
• Patients previously received chest X-ray, electrocardiography, echocardiography, other routine examinations, and RHC at the Fuwai Hospital, CAMS & PUMC, Beijing, China

Exclusion criteria

• Patients without RHC
• The quality of routine examinations and RHC cannot meet the requirement for further analysis
• Severe loss of results of routine examinations (chest X-ray, electrocardiography, echocardiography, etc.)

Trial design

2,000 participants in 2 patient groups

Patients with pulmonary hypertension

Description:

A series of routine examinations, including chest X-ray, electrocardiography, echocardiography, etc, would be performed on consecutive patients at Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. An RHC with an mPAP of \>20 mmHg would confirm the diagnosis of PH. All these data will be collected as a source for machine learning or other artificial intelligence-assisted programs.

Treatment:

Diagnostic Test: Right heart catheterization

Patients without pulmonary hypertension

Description:

A series of routine examinations, including chest X-ray, electrocardiography, echocardiography, etc, would be performed on consecutive patients at Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. An RHC with an mPAP of ≤20 mmHg would confirm the absence of PH. All these data will be collected as a source for machine learning or other artificial intelligence-assisted programs.

Treatment:

Diagnostic Test: Right heart catheterization