Prospective Cardiac Ultrasound Imaging Study With Demonstrator

NCT05850741 | Completed

• 1 other identifier: IRCCSSanMatteoPavia
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The Prospective Cardiac Ultrasound Imaging Study is a single center, single arm, feasibility study. The study aims at collecting cardiac ultrasound data from patients diagnosed with ventricular tachycardia, during rest and short breath hold sequences. This study is part of the engineering studies linked to the CardioKit-Minimum Viable Product project. The CardioKit prototype used in the study can monitor cyclical heart-beat motion, cyclical respiratory motion and non-cyclical heart position changes while the patient is lying in supine position.

Conditions

Ventricular Tachycardia

Keywords

artificial intelligence; cardiac radioablation; echocardiography; motion monitoring; ventricular arrhythmia

Outcome Measures

Primary Outcomes (4)

• Image quality in terms of allowing a correct identification of the phase of the cardiac cycle by the prototype software.

  The primary endpoint was defined as the percentage of patients able to obtain a positive result in a multi parametric score of image quality, consisting of: Score = 1: average phase error per patient, defined as the difference between the phase of the cardiac cycle identified by the algorithm and the one evaluated by the ECG reference \<0.1. Score = 0: average phase error per patient ≥0.1. For each patient, scoring was done for each imaging view (i.e., parasternal and apical). If the score was 2 (at least 1 point in A or B and 1 point in C or D) or greater for at least one of the imaging views, the outcome was considered as positive. The final result is the proportion of patients (in %) with a positive outcome, defined as the number of patients with a positive evaluation divided by the total number of patients x 100.

  Baseline

• Image quality in terms of allowing a correct measurement of the heart displacement (mainly due to respiratory motion) by the prototype software.

  The primary endpoint was defined as the percentage of patients able to obtain a positive result in a multi parametric score of image quality, consisting of: Score = 1: maximum excursion calculated by the algorithm \<30 mm with a total 3D error in the calculation of the displacement \<3 mm. Score = 0: either maximum excursion calculated by the algorithm ≥30 mm or total 3D error in the calculation of the displacement ≥3 mm (or both). For each patient, scoring was done for each imaging view (i.e., parasternal and apical). If the score was 2 (at least 1 point in A or B and 1 point in C or D) or greater for at least one of the imaging views, the outcome was considered as positive. The final result is the proportion of patients (in %) with a positive outcome, defined as the number of patients with a positive evaluation divided by the total number of patients x 100.

  Baseline

• Image quality in terms of the ability to distinguish typical cardiac structures, as assessed visually by the clinical operator.

  The primary endpoint was defined as the percentage of patients able to obtain a positive result in a multi parametric score of image quality, consisting of: Score = 1: ability to identify visually by an experienced operator in the acquired image at least one of the following structures: left ventricular free wall, interventricular septum, mitral valve, or aortic valve. Score = 0: inability to identify at least one of these structures. For each patient, scoring was done for each imaging view (i.e., parasternal and apical). If the score was 2 (at least 1 point in A or B and 1 point in C or D) or greater for at least one of the imaging views, the outcome was considered as positive. The final result is the proportion of patients (in %) with a positive outcome, defined as the number of patients with a positive evaluation divided by the total number of patients x 100.

  Baseline

• Image quality in terms of the stability of the image throughout the respiration cycle, as assessed visually by the clinical operator.

  The primary endpoint was defined as the percentage of patients able to obtain a positive result in a multi parametric score of image quality, consisting of: Score = 1: persistence of cardiac structures within the echocardiographic image during respiratory motion. Score = 0: disappearance of cardiac structures from the echocardiographic image during respiratory motion. For each patient, scoring was done for each imaging view (i.e., parasternal and apical). If the score was 2 (at least 1 point in A or B and 1 point in C or D) or greater for at least one of the imaging views, the outcome was considered as positive. The final result is the proportion of patients (in %) with a positive outcome, defined as the number of patients with a positive evaluation divided by the total number of patients x 100.

  Baseline

Study Arms (1)

Device

EXPERIMENTAL

The following procedure steps will take place: * The study system is installed in the room before patient arrival * The patient needs to fully undress the upper body before lying on the bed * The 3 ECG electrodes are placed * Ultrasound gel is applied on the ultrasound probe

Device: Cardiokit

Interventions

Cardiokit DEVICE

The CardioKit prototype used in the study can monitor cyclical heart-beat motion, cyclical respiratory motion and non-cyclical heart position changes while the patient is lying in supine position.

Device

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient with history of ventricular tachycardia
• Over 18 years old
• Ability and willingness to provide written informed consent

You may not qualify if:

• \. Patient in arrhythmic storm

Sponsors & Collaborators

• Fondazione IRCCS Policlinico San Matteo di Pavia: lead

Study Sites (1)

IRCCS Policlinico San Matteo

Pavia, 27100, Italy

Location

MeSH Terms

Conditions

Tachycardia, Ventricular

Condition Hierarchy (Ancestors)

Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Roberto Rordorf, md

  Fondazione IRCCS Policlinico San Matteo di Pavia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 29, 2023
• First Posted: May 9, 2023
• Study Start: June 4, 2021
• Primary Completion: July 5, 2021
• Study Completion: February 3, 2022
• Last Updated: May 16, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)