Actively Recruiting
Validation of a Machine Learning Predictive Model to Distinguish Post-capillary Pulmonary Hypertension
Led by KU Leuven · Updated on 2024-05-08
100
Participants Needed
4
Research Sites
101 weeks
Total Duration
On this page
Sponsors
K
KU Leuven
Lead Sponsor
R
Research Foundation Flanders
Collaborating Sponsor
AI-Summary
What this Trial Is About
In this study the diagnostic accuracy of a diagnostic tool for the diagnosis of post-capillary pulmonary hypertension will be investigated. The diagnostic tool was designed based on artificial intelligence, using machine learning on a database of 344 patients with group 1 or group 2 pulmonary hypertension. The tool uses 20 non-invasive parameters which are derived from laboratory results, ECG, echocardiography and spirometry. Based on these parameters, the predictive tool estimates the probability of group 2 pulmonary hypertension. During this clinical study, patients with an intermediate or high suspicion of pulmonary hypertension, with an indication for a diagnostic right heart catheterization, will be included. Patients with risk factors for group 3, 4 or 5 pulmonary hypertension will be excluded. The necessary parameters to run the predictive model will be extracted from the patients medical file. Patients will undergo a standard of care right heart catheterization (gold standard). Afterwards the results of the predictive model will be compared to those of the right heart catheterization, to allow the assessment of the sensitivity, specificity, positive and negative predictive value of the predictive tool.
CONDITIONS
Official Title
Validation of a Machine Learning Predictive Model to Distinguish Post-capillary Pulmonary Hypertension
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntary written informed consent given before any screening procedures
- Male or female patients aged 18 years or older
- Availability of results from basic work-up including medical history, demographics, clinical information (including BMI), laboratory tests (hemoglobin, hematocrit, uric acid), ECG, pulmonary function tests, and echocardiography
- Intermediate to high probability of pulmonary hypertension based on echocardiography according to 2022 ESC/ERS guidelines
- Indication for right heart catheterization according to 2022 ESC/ERS guidelines
You will not qualify if you...
- Significant pulmonary comorbidity with abnormal pulmonary function tests (FEV1 below 60%) or lung parenchyma abnormalities more than mild on imaging
- Perfusion defects and ventilation mismatch on recent V/Q scan
- Arterial perfusion defects on recent thoracic CT angiography
- Comorbidities associated with group 1 pulmonary hypertension: connective tissue disease, HIV infection, portal hypertension, congenital heart disease
- Comorbidities associated with group 5 pulmonary hypertension: hematological disorders (chronic hemolytic anemia, myeloproliferative disorders), systemic and metabolic disorders (pulmonary Langerhans cell histiocytosis, Gaucher disease, glycogen storage diseases, neurofibromatosis, sarcoidosis), chronic renal failure (eGFR below 30 ml/min) with or without hemodialysis, fibrosing mediastinitis
AI-Screening
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Trial Site Locations
Total: 4 locations
1
Ziekenhuis Oost-Limburg
Genk, Limburg, Belgium, 3600
Actively Recruiting
2
Jessa Hospital
Hasselt, Limburg, Belgium, 3500
Actively Recruiting
3
UZ Leuven
Leuven, Vlaams Brabant, Belgium, 3000
Actively Recruiting
4
AZ Groeninge
Kortrijk, West-Vlaanderen, Belgium, 8500
Actively Recruiting
Research Team
L
Laura Hardy, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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