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OpenTrials
Completed

NCT Number: NCT05850741

Prospective Cardiac Ultrasound Imaging Study With Demonstrator

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.

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Key information

Conditions

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

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IRCCS Policlinico San Matteo

Pavia, 27100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Patient in arrhythmic storm

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Policlinico San Matteo di Pavia

Other

Registry information

Acronym: CARDIOKIT

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
May 9, 2023
Registry last updated
May 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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