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Artificial Intelligence-assisted Evaluation of Pulmonary HYpertension

Artificial Intelligence-Assisted Evaluation of Pulmonary Hypertension

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05566002
Acronym
AIPHY
Enrollment
2000
Registered
2022-10-04
Start date
2022-06-01
Completion date
2025-12-31
Last updated
2025-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Hypertension, Pulmonary Arterial Hypertension

Keywords

pulmonary hypertension, pulmonary vascular disease, right heart catheterization, echocardiography, electrocardiography, chest X-ray, artificial intelligence, machine learning, deep learning, screening, diagnosis

Brief summary

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.

Detailed 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.

Interventions

RHC is commonly used essential test to make gold-standard diagnosis of PH with mPAP \>20 mmHg. All multimodal data from patients eligible for inclusion would be randomly assigned to development datasets (70% of the study population) to train the artificial intelligence models for the detection of PH, which would be validated and tested by other datasets (30% of the study population).

Sponsors

Chinese Pulmonary Vascular Disease Research Group
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.)

Design outcomes

Primary

MeasureTime frameDescription
Accuracy of diagnosis by artificial intelligence-assisted algorithmBaselineThe investigators will calculate the area under the receiver operating characteristic curve of diagnosis by artificial intelligence-assisted algorithm and compare this index between artificial intelligence-assisted algorithm and RHC.

Secondary

MeasureTime frameDescription
Sensitivity of diagnosis by artificial intelligence algorithmBaselineThe investigators will calculate the sensitivity of diagnosis by artificial intelligence-assisted algorithm and compare this index between artificial intelligence-assisted algorithm and RHC.
Specificity of diagnosis by artificial intelligence algorithmBaselineThe investigators will calculate the sensitivity of diagnosis by artificial intelligence-assisted algorithm and compare this index between artificial intelligence-assisted algorithm and RHC.

Countries

China

Contacts

Primary ContactZhihong Liu, MD, PhD
zhihongliufuwai@163.com13269276067

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026