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.
Study Type
OBSERVATIONAL
Enrollment
100
Patient data will be extracted to run the predictive model, which will estimate the probability of group 2 pulmonary hypertension. However the results of the model will have no diagnostic or therapeutic implications in this phase of the investigation.
Ziekenhuis Oost-Limburg
Genk, Limburg, Belgium
RECRUITINGJessa Hospital
Hasselt, Limburg, Belgium
RECRUITINGUZ Leuven
Leuven, Vlaams Brabant, Belgium
RECRUITINGAZ Groeninge
Kortrijk, West-Vlaanderen, Belgium
RECRUITINGDiagnostic accuracy of the Optiek model
sensitivity, specificity, positive and negative predictive value of the model compared to a right heart catheterization (gold standard)
Time frame: 18 months
Number of right heart catheterizations which could have been avoided
The number of avoidable rght heart catheterizations will be derived from the sensitivity of the model.
Time frame: 18 months
Right heart catheterization related adverse events
All subsequent adverse events will be registered in the eCRF.
Time frame: 18 months
Feasibility of the implementation of the Optiek model in clinical practice
The feasibility will be assessed using a questionnaire adressed to the physicians using the model.
Time frame: 18 months
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