Artificial Intelligence in PAH-SSc (ARENAS)

Status: Recruiting
Location: See all (5) locations...
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
Spain
Hospital Universitario Vall d'Hebron
RECRUITING
Barcelona
Hospital Universitario Clínico San Cecilio
RECRUITING
Granada
Hospital Universitario 12 de Octubre
RECRUITING
Madrid
Hospital Universitario Ramón y Cajal
RECRUITING
Madrid
Hospital Universitario Marqués de Valdecilla
RECRUITING
Santander
Time Frame
Start Date: 2025-05-30
Estimated Completion Date: 2027-12
Participants
Target number of participants: 350
Treatments
Cohort 1
Development cohort for an AI model based on widely available clinical data. 300 controls with Systemic Sclerosis (SSc) without Pulmonary Hypertension (PAH) and 50 cases of SSc with PAH
Cohort 2
External validation of the screening model: 200 controls with SSc without PAH and 50 cases with PAH associated with SSc
Cohort 3
Prognostic models including protein analysis, cardiac imaging, PREMS and PROMS: 100 patients with PAH-SSc
Sponsors
Leads: Alejandro Cruz Utrilla

This content was sourced from clinicaltrials.gov

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