In-depth ECG Analysis for the Extraction of Biomarkers of Cardiac Mechanical Dispersion (AFICIONADO)

Left ventricular systolic dysfunction (LVSD) refers to impaired contraction of the left ventricle, and can lead to heart failure and death. Early identification of LVSD, which often remains asymptomatic for years, is therefore crucial to mitigate the associated risks through appropriate treatment. Echocardiographic screening of asymptomatic individuals is costly, requires access to experts, and the criteria for selecting potential high-risk individuals for screening remain unclear.

Unlike echocardiography, the electrocardiogram (ECG) is a relatively low-cost procedure, routinely available and requiring little technical training to set up the examination and collect data, making it an interesting tool for early detection of LVSD.

Study Overview

• Status: Not yet recruiting
• Conditions: Cardiovascular Pathology
• Intervention / Treatment: Device: ECG; Device: Echocardiography

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

Study Locations

• France
  • CHRU De Nancy
    • Vandœuvre-lès-Nancy, CHRU De Nancy, France, 54511
      • Chru Nancy
      • Contact: Olivier HUTTIN, MD, PhD; Phone Number: +33 385157355; Email: o.huttin@chru-nancy.fr
      • Contact: Guillaume DROUOT, PhD; Phone Number: +33 383157666; Email: g.drouot@chru-nancy.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

Patients seen in consultation at the Cardiology Department of the Nancy CHRU who performed an echocardiography and a 12-lead ECG.

Description

Inclusion Criteria:

• Person who has received full information on the organization of the research and has not objected to the use of this data;
• Age ≥ 50;
• Persons who have undergone an echocardiographic examination and a 12-lead ECG examination during consultations at the CHRU de Nancy;
• Persons with at least one cardiovascular risk (obesity, diabetes, hypertension, etc.).

Exclusion Criteria:

• People with a history of heart disease (ischemic, valvular);
• Patients with significant 12-lead ECG abnormalities (complete bundle branch block, sequelae of myocardial infarction, etc.);
• ECG tracings or echocardiograms that cannot be analyzed.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
No myocardial contractility abnormalities	Device: ECG; Routine care 12-lead electrocardiogram; Device: Echocardiography; Routine care echocardiography
Myocardial contractility abnormalities	Device: ECG; Routine care 12-lead electrocardiogram; Device: Echocardiography; Routine care echocardiography

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
F1 score for classification of cardiac contractility abnormalities	12 months

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2023
• Primary Completion (Estimated): November 30, 2024
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: December 1, 2023
• First Submitted That Met QC Criteria: December 1, 2023
• First Posted (Actual): December 11, 2023

Study Record Updates

• Last Update Posted (Actual): December 11, 2023
• Last Update Submitted That Met QC Criteria: December 1, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 2023PI117

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No