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NCT Number: NCT05566002

Artificial Intelligence-assisted Evaluation of Pulmonary HYpertension

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, Beijing Municipality, 100037, China

Location status: Recruiting

Location contact

Zhihong Liu, MD, PhD

CONTACT

[email protected]

13269276067

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

Right heart catheterization

Diagnostic Test

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).

Primary outcomes

  1. Accuracy of diagnosis by artificial intelligence-assisted algorithm

    Time frame: Baseline

    The 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 outcomes

  1. Sensitivity of diagnosis by artificial intelligence algorithm

    Time frame: Baseline

    The investigators will calculate the sensitivity of diagnosis by artificial intelligence-assisted algorithm and compare this index between artificial intelligence-assisted algorithm and RHC.

  2. Specificity of diagnosis by artificial intelligence algorithm

    Time frame: Baseline

    The investigators will calculate the sensitivity of diagnosis by artificial intelligence-assisted algorithm and compare this index between artificial intelligence-assisted algorithm and RHC.

Study contacts

Contact information is provided by the study sponsor or research team.

Zhihong Liu, MD, PhD

CONTACT

[email protected]

13269276067

Sponsors and collaborators

Lead sponsor

Chinese Pulmonary Vascular Disease Research Group

Other

Registry information

Acronym: AIPHY

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Oct 4, 2022
Registry last updated
Apr 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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