The Echodynamic Approach
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIRCCS Ospedale San Raffaele
About this trial
The aim of this prospective observational study is to assess the accuracy of non-invasive hemodynamic parameter estimation via trans-thoracic echocardiography (TTE) compared to the invasive gold standard of right heart catheterization (RHC). This study will include patients who undergo both TTE and RHC on the same day, under the same hemodynamic conditions. The primary research question is: how does the echodynamic evaluation perform compared to right heart catheterization?
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Clinical need for an invasive hemodynamic assessment and an echocardiographic evaluation on the same day
Disqualifiers
Incomplete hemodynamic assessment for any reason
Trial population
The study population consists of patients from multiple centers who received, within a short time frame (the same day), an invasive assessment of hemodynamic parameters through right heart catheterization and a non-invasive assessment through echocardiography.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Cardiac output
The primary outcome will be to compare the estimated value using echocardiographic parameters with the same invasive measurement by right heart catheterization recorded on the same day to avoid different cardiac load conditions. Right heart catheterization will be from either femural or jugular vein approach. The measure's unit will be L/min and L/min/m\^2 for the indexed value.
Time frame
Baseline2
Pulmonary artery pressure
The primary outcome will be to compare the estimated values using echocardiographic parameters with the same invasive measurement by right heart catheterization recorded on the same day to avoid different cardiac load conditions. Right heart catheterization will be from either femural or jugular vein approach. The measure's unit will be in mmHg, and it will be expressed as systolic, mean and diastolic pulmonary pressure.
Time frame
Baseline3
Pulmonary vascular resistance
The primary outcome will be to compare the estimated values using echocardiographic parameters with the same invasive measurement by right heart catheterization recorded on the same day to avoid different cardiac load conditions. Right heart catheterization will be from either femural or jugular vein approach. The measure's unit will be in Woods Units
Time frame
Baseline4
Right atrial pressure
The primary outcome will be to compare the estimated values using echocardiographic parameters with the same invasive measurement by right heart catheterization recorded on the same day to avoid different cardiac load conditions. Right heart catheterization will be from either femural or jugular vein approach. The measure's unit will be in mmHg.
Time frame
BaselineSponsors and contacts
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Source ClinicalTrials.gov