Actively Recruiting

Age: 18Years - 80Years
All Genders
NCT07236970

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

Led by Alejandro Cruz Utrilla · Updated on 2025-11-19

350

Participants Needed

5

Research Sites

130 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Clinical diagnosis of systemic sclerosis (SSc) according to ACR/EULAR criteria
  • For controls (SSc without PAH): no pulmonary arterial hypertension; may include up to 20% with isolated or combined post-capillary pulmonary hypertension or Group 3 pulmonary hypertension
  • For cases (SSc-associated PAH): confirmed PAH by right heart catheterization with mean pulmonary arterial pressure > 20 mmHg, pulmonary capillary pressure < 15 mmHg, and pulmonary vascular resistance > 2 Wood Units
Not Eligible

You will not qualify if you...

  • Missing data in key diagnostic variables including clinical assessment, blood tests, electrocardiogram, or transthoracic echocardiogram
  • Inability to provide informed consent

AI-Screening

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Trial Site Locations

Total: 5 locations

1

Hospital Universitario Clínico San Cecilio

Granada, Andalusia, Spain, 18007

Actively Recruiting

2

Hospital Universitario Marqués de Valdecilla

Santander, Cantabria, Spain, 39008

Actively Recruiting

3

Hospital Universitario Vall d'Hebron

Barcelona, Catalonia, Spain, 08035

Actively Recruiting

4

Hospital Universitario Ramón y Cajal

Madrid, Madrid, Spain, 28034

Actively Recruiting

5

Hospital Universitario 12 de Octubre

Madrid, Madrid, Spain, 28041

Actively Recruiting

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How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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