Evaluation of Clinical Intelligence Support to Reduce Errors in Normal ECGs

NCT ID: NCT07179185

Last Updated: 2025-09-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

710 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-01

Study Completion Date

2025-11-30

Brief Summary

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This study will evaluate the performance of specialist physicians in interpreting normal electrocardiograms (ECGs) with and without the assistance of an artificial intelligence (AI) neural network. The primary aim is to determine whether AI support affects the rate of false-positive interpretations of normal tracings. Secondary aims include evaluating the time required for interpretation, the sensitivity for detecting abnormalities, and the effect on false positives in ECGs with major abnormalities according to the Minnesota Code system. All ECGs in the sample will be reviewed by a panel of three specialists, to determine the reference classification.

Detailed Description

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Conditions

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Electrocardiogram Cardiovascular Abnormalities

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Control - Specialist Interpretation Without AI

Specialist physicians interpret normal ECGs without the assistance of the AI-ECG tool. ECGs are routine tracings performed by the Rede de Telemedicina de Minas Gerais (RTMG). Final classification for study endpoints will be based on a panel review by three specialists.

Group Type ACTIVE_COMPARATOR

Specialist ECG Interpretation Without AI

Intervention Type DIAGNOSTIC_TEST

Manual interpretation of ECGs by specialists without AI support, following standard diagnostic procedures

Specialist interpretation with AI assistance

Specialist physicians interpret ECGs using the AI-ECG tool, which provides automated classification support indicating whether the ECG is normal or not. ECGs are routine tracings performed by RTMG. Final classification for study endpoints will be based on a panel review by three specialists.

Group Type EXPERIMENTAL

AI-Assisted ECG Interpretation (AI-ECG)

Intervention Type DIAGNOSTIC_TEST

Neural network-based AI software that analyzes ECG tracings and provides a classification as normal suggestion to the interpreting specialist.

Interventions

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AI-Assisted ECG Interpretation (AI-ECG)

Neural network-based AI software that analyzes ECG tracings and provides a classification as normal suggestion to the interpreting specialist.

Intervention Type DIAGNOSTIC_TEST

Specialist ECG Interpretation Without AI

Manual interpretation of ECGs by specialists without AI support, following standard diagnostic procedures

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* ECGs performed routinely by the Rede de Telemedicina de Minas Gerais (RTMG)

Exclusion Criteria

* ECGs from patients younger than 18 years
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Uppsala University

OTHER

Sponsor Role collaborator

Federal University of Minas Gerais

OTHER

Sponsor Role lead

Responsible Party

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Antonio Luiz Pinho Ribeiro

Full Professor, Internal Medicine Department, School of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Antonio Luiz P. Ribeiro, MD, PhD

Role: CONTACT

55(31)3307-9201

Gabriela Miana M. Paixão, MD, PhD

Role: CONTACT

55(31) 3307-9201

References

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Oliveira CRA, Paixao GMM, Tostes VC, Gomes PR, Mendes MS, Paixao MC, Marcolino MS, Ribeiro ALP. Upscaling a regional telecardiology service to a nationwide coverage and beyond: the experience of the Telehealth Network of Minas Gerais. BMJ Glob Health. 2025 Jan 19;10(1):e016692. doi: 10.1136/bmjgh-2024-016692.

Reference Type BACKGROUND
PMID: 39828428 (View on PubMed)

Ribeiro ALP, Paixao GMM, Gomes PR, Ribeiro MH, Ribeiro AH, Canazart JA, Oliveira DM, Ferreira MP, Lima EM, Moraes JL, Castro N, Ribeiro LB, Macfarlane PW. Tele-electrocardiography and bigdata: The CODE (Clinical Outcomes in Digital Electrocardiography) study. J Electrocardiol. 2019 Nov-Dec;57S:S75-S78. doi: 10.1016/j.jelectrocard.2019.09.008. Epub 2019 Sep 7.

Reference Type BACKGROUND
PMID: 31526573 (View on PubMed)

Ribeiro AH, Ribeiro MH, Paixao GMM, Oliveira DM, Gomes PR, Canazart JA, Ferreira MPS, Andersson CR, Macfarlane PW, Meira W Jr, Schon TB, Ribeiro ALP. Automatic diagnosis of the 12-lead ECG using a deep neural network. Nat Commun. 2020 Apr 9;11(1):1760. doi: 10.1038/s41467-020-15432-4.

Reference Type BACKGROUND
PMID: 32273514 (View on PubMed)

Other Identifiers

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409604/2022-4

Identifier Type: -

Identifier Source: org_study_id

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