AI-based screening models for pulmonary arterial hypertension in people with systemic sclerosis
"Artificial Intelligence in PAH-SSc (ARENAS) "
This project will test whether artificial intelligence models using clinical, lab, ECG, and echocardiogram data can better screen adults with systemic sclerosis for pulmonary arterial hypertension.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 350 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Hospital Universitario 12 de Octubre Academic / other |
| Locations | 5 sites (Granada, Andalusia and 4 other locations) |
| Trial ID | NCT07236970 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (≥18) with a clinical diagnosis of systemic sclerosis who can provide informed consent are ideal, including both patients with right-heart-catheterization–confirmed PAH and SSc patients without PAH for controls.
Not a fit: People without sufficient clinical/laboratory/ECG/echo data, minors, or patients whose pulmonary hypertension is from non-SSc causes are unlikely to benefit from these screening models.
Why it matters
Potential benefit: If successful, the approach could enable earlier and more accurate detection of PAH in people with SSc, allowing earlier treatment and potentially better outcomes.
How similar studies have performed: Classical screening programs for SSc-PAH have improved early detection and outcomes, but applying artificial intelligence to this screening task is relatively new and has limited prior external validation.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Granada, Andalusia and 4 other locations
- 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)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.