RECRUITING

Assessment of Left Ventricular Filling Pressure by Applying Artificial Intelligence Algorithms to Left Atrial Speckle-tracking Echocardiography

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Conditions

Heart Failure, DiastolicEchocardiographyTransthoracic echocardiographyleft ventricular filling pressureartificial intelligenceright heart catheterization

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this single-center, prospective, observational study is to validate a software package based on an artificial intelligence algorithm for automated non-invasive estimation of LVFP against invasively measured ones by left and right heart catheterization; In addition, the added value of this new automated software to detect increased LVEDP \> 15 mm Hg compared to the current ASE/EACVI algorithm for assessing diastolic dysfunction and longitudinal left atrial strain during the reservoir phase will be evaluated.

Official Title

Valutazione Delle Pressioni di Riempimento Del Ventricolo Sinistro Attraverso l'Impiego di un Software di Intelligenza Artificiale Applicato Alla Stima Dello Strain Atriale Sinistro Con Ecocardiografia Speckletracking: Studio di Validazione Mediante Cateterismo Cardiaco

Quick Facts

Study Start:2021-07-20
Study Completion:2024-06-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05768698

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Not specified
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * ≥ 18 yo,
  2. * Signed informed consent to be part of this study,
  3. * No pregnancy,
  4. * Good acoustic window and patient cooperation to obtain good 2- and 3-dimensional datasets focused on left atrium (LA),
  1. * Unwillingness to be part of the study,
  2. * Patients with poor 2-dimensional imaging quality in ≥ 1 LA segment or lacking of a discernible R-R interval, which might preclude accurate strain measurements,
  3. * Patients with more than mild mitral valve heart disease, aortic regurgitation, left side valvular prosthesis or mitral valve repair, mitral annulus calcification (≥ 5 mm),
  4. * Patients with history or presence of atrial fibrillation (AF), supraventricular arrhythmias, ventricular paced rhythm, left bundle branch block (LBBB),
  5. * Patients taking diuretics or vasodilators (nitrates) on the day of the examination, which could alter loading conditions.

Contacts and Locations

Study Contact

Luigi Badano, MD, Ph.D.
CONTACT
+390261911
l.badano@auxologico.it
Sergio Caravita, MD, Ph.D.
CONTACT
+390261911
s.caravita@auxologico.it

Study Locations (Sites)

Philips Healthcare
Andover, Massachusetts, 01810
United States

Collaborators and Investigators

Sponsor: Istituto Auxologico Italiano

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 Registration Dates

Study Start Date2021-07-20
Study Completion Date2024-06-11

Study Record Updates

Study Start Date2021-07-20
Study Completion Date2024-06-11

Terms related to this study

Keywords Provided by Researchers

  • Transthoracic echocardiography
  • left ventricular filling pressure
  • artificial intelligence
  • right heart catheterization

Additional Relevant MeSH Terms

  • Heart Failure, Diastolic
  • Echocardiography