CARDIOKIT: Prospective Cardiac Ultrasound Imaging Study With Demonstrator

Sponsor

Fondazione IRCCS Policlinico San Matteo di Pavia (Other)

Overall Status

Completed

CT.gov ID

NCT05850741

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ventricular Tachycardia	Device: Cardiokit	N/A

Detailed Description

The research will analyse the ultrasound image data quality, especially investigating the ability of the prototype system to automatically and correctly interpret ultrasound images and artifact issues which may arise from age, body composition, mechanical valves, leads from implanted devices, or other implants. The study will establish if it is appropriate to develop a new medical device supporting automated cardiac ultrasound image interpretation during non-invasive cardiac procedures, i.e. ventricular tachycardia stereotactic radioablation. This early research protocol did collect data from 24 adult patients. The data were not used for diagnostic nor treatment purposes and the protocol's procedure duration was limited to one hour, hence the research was considered of very limited risk for the participants. The research will provide a Proof-of-Concept for a Medical Device to benefit patients with ventricular tachycardia and other cardiac pathologies in the future.

Study Design

Study Type:

Interventional

Actual Enrollment :

24 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Prospective Cardiac Ultrasound Imaging Study With Demonstrator

Actual Study Start Date :

Jun 4, 2021

Actual Primary Completion Date :

Jul 5, 2021

Actual Study Completion Date :

Feb 3, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Device 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 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.

Arm

Intervention/Treatment

Experimental: Device

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

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.

Outcome Measures

Primary Outcome Measures

Image quality in terms of allowing a correct identification of the phase of the cardiac cycle by the prototype software. [Baseline]
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.
Image quality in terms of allowing a correct measurement of the heart displacement (mainly due to respiratory motion) by the prototype software. [Baseline]
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.
Image quality in terms of the ability to distinguish typical cardiac structures, as assessed visually by the clinical operator. [Baseline]
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.
Image quality in terms of the stability of the image throughout the respiration cycle, as assessed visually by the clinical operator. [Baseline]
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.