The Echodynamic Approach (TECH)

March 17, 2025 updated by: Carlo Gaspardone, IRCCS Ospedale San Raffaele

Comprehensive Hemodynamic Assessment Via Echocardiography: the Echodynamic Approach Compared to Right Heart Catheterization

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?

Study Overview

Status

Recruiting

Conditions

Detailed Description

The non-invasive echocardiographic assessment will be used to esimate via mathematic formulas all the direct and indirect paramethers obtained from the right side catheterization. Each value obtained from the model using echocardiographic paramethers will be compared to the invasive finding.

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Carlo Garspardone, Medical Doctor
Phone Number: +393389920314
Email: gaspardone.carlo@hsr.it

Study Locations

Italy
- - Bari, Italy
    - Recruiting
    - Ospedale Generale regionale "F.Miulli"
    - Contact:
      
      Fabrizio Fortunato
      
      Phone Number: +393489269237
      
      Email: fabrizio.fortunato1@gmail.com
  - Milan, Italy
    - Recruiting
    - IRCCS Ospedale San Raffaele
    - Contact:
      
      Carlo Gaspardone
      
      Phone Number: +393389920314
      
      Email: gaspardone.carlo@hsr.it
  - Pavia, Italy
    - Recruiting
    - IRCCS Policlinico San Matteo Pavia
    - Contact:
      
      Alessandro Fasolino
      
      Phone Number: +393385754572
      
      Email: alessandro.fasolino01@universitadipavia.it

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Sampling Method

Non-Probability Sample

Study 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.

Description

Inclusion Criteria:

Clinical need for an invasive hemodynamic assessment and an echocardiographic evaluation on the same day

Exclusion Criteria:

Incomplete hemodynamic assessment for any reason

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiac output Time Frame: Baseline	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.	Baseline
Pulmonary artery pressure Time Frame: Baseline	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.	Baseline
Pulmonary vascular resistance Time Frame: Baseline	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	Baseline
Right atrial pressure Time Frame: Baseline	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.	Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Ospedale San Raffaele

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

February 22, 2025

First Submitted That Met QC Criteria

February 27, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)