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RECRUITINGOBSERVATIONAL

Multicenter Study on the Development of Pulmonary Arterial Hypertension Screening Models Based on Artificial Intelligence for Patients With Systemic Sclerosis

"Artificial Intelligence in PAH-SSc (ARENAS) "

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

Pulmonary Arterial Hypertension (PAH) is a rare and severe condition that can be associated with Systemic Sclerosis (SSc), significantly worsening the prognosis of the latter disease. Screening programs based on clinical, laboratory, pulmonary function test, electrocardiographic, and echocardiographic data have been shown to enable earlier diagnosis and improve the prognosis of PAH associated with SSc. However, the hemodynamic criteria for the diagnosis of PAH have recently changed, and the usefulness of these screening programs in this new context is unknown. The primary objective of this study is to develop a PAH screening program in patients with SSc through the use of different artificial intelligence algorithms, comparing these algorithms with classical screening programs. These algorithms will be externally validated in different hospitals in Spain. As secondary objectives, the study will assess the usefulness of various proteins involved in the metabolic pathways related to the development of PAH, as well as certain parameters of right ventricular function and measures of quality-of-life impact, in the prognostic evaluation of PAH associated with SSc. To this end, simple and reproducible clinical data will be used, such as electrocardiogram, echocardiogram, and different quality-of-life scales obtained from major PAH and SSc registries. Machine learning techniques and Bayesian networks will be applied to generate artificial intelligence models for screening and prognostic assessment.

Who May Be Eligible (Plain English)

Who May Qualify: - Age ≥ 18 years - Clinical diagnosis of systemic sclerosis (SSc) according to ACR/EULAR criteria - For controls (SSc without PAH): absence of pulmonary arterial hypertension; patients with isolated or combined post-capillary pulmonary hypertension (pulmonary capillary pressure \> 15 mmHg) or Group 3 pulmonary hypertension may be included, limited to 20% of this group - For cases (SSc-associated PAH): confirmed PAH by right heart catheterization (mean pulmonary arterial pressure \> 20 mmHg, pulmonary capillary pressure \< 15 mmHg, pulmonary vascular resistance \> 2 Wood Units) Who Should NOT Join This Trial: - Missing data in the main variables at diagnosis (clinical assessment, blood tests, electrocardiogram, transthoracic echocardiogram). - Inability to provide willing to sign a consent form Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * Age ≥ 18 years * Clinical diagnosis of systemic sclerosis (SSc) according to ACR/EULAR criteria * For controls (SSc without PAH): absence of pulmonary arterial hypertension; patients with isolated or combined post-capillary pulmonary hypertension (pulmonary capillary pressure \> 15 mmHg) or Group 3 pulmonary hypertension may be included, limited to 20% of this group * For cases (SSc-associated PAH): confirmed PAH by right heart catheterization (mean pulmonary arterial pressure \> 20 mmHg, pulmonary capillary pressure \< 15 mmHg, pulmonary vascular resistance \> 2 Wood Units) Exclusion Criteria: * Missing data in the main variables at diagnosis (clinical assessment, blood tests, electrocardiogram, transthoracic echocardiogram). * Inability to provide informed consent

Locations (5)

Hospital Universitario Clínico San Cecilio
Granada, Andalusia, Spain
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, Spain
Hospital Universitario Vall d'Hebron
Barcelona, Catalonia, Spain
Hospital Universitario Ramón y Cajal
Madrid, Madrid, Spain
Hospital Universitario 12 de Octubre
Madrid, Madrid, Spain