AI-based screening models for pulmonary arterial hypertension in people with systemic sclerosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter observational study will develop and compare several artificial intelligence algorithms that use clinical, laboratory, pulmonary function, electrocardiographic, and echocardiographic data to identify pulmonary arterial hypertension (PAH) in patients with systemic sclerosis (SSc). Algorithms will be trained on retrospectively and/or prospectively collected data and compared with existing classical screening programs, then externally validated across hospitals in Spain. Cases are defined by right heart catheterization using the updated hemodynamic criteria and controls are SSc patients without PAH (with limited inclusion of other PH types). The study also explores circulating proteins related to metabolic pathways as secondary biomarkers to complement the models.

Why it matters

Who can join: the full rules

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

Where it's running

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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.