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

NCT06163911 | Unknown

• 1 other identifier: 2023PI117
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cardiovascular Pathology

Outcome Measures

Primary Outcomes (1)

• F1 score for classification of cardiac contractility abnormalities

  12 months

Study Arms (2)

No myocardial contractility abnormalities

Device: ECG; Device: Echocardiography

Myocardial contractility abnormalities

Device: ECG; Device: Echocardiography

Interventions

ECG DEVICE

Routine care 12-lead electrocardiogram

Myocardial contractility abnormalities; No myocardial contractility abnormalities

Echocardiography DEVICE

Routine care echocardiography

Myocardial contractility abnormalities; No myocardial contractility abnormalities

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

CHRU Nancy

Vandœuvre-lès-Nancy, CHRU de Nancy, 54511, France

Location

MeSH Terms

Interventions

Electrocardiography; Echocardiography

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis; Cardiac Imaging Techniques; Diagnostic Imaging; Ultrasonography

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 1, 2023
• First Posted: December 11, 2023
• Study Start: December 1, 2023
• Primary Completion: November 30, 2024
• Study Completion: June 1, 2025
• Last Updated: December 11, 2023

Record last verified: 2023-12

Locations

FR (1)