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

Cardiovascular Pathology Clinical Trial

— AFICIONADO  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06163911
• Other study ID #: 2023PI117
• Status: Not yet recruiting
• Start date: December 1, 2023
• Est. completion date: June 1, 2025

Study information

• Verified date: December 2023
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: June 1, 2025
• Est. primary completion date: November 30, 2024
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Pathology

Intervention

Device:
• ECG
Routine care 12-lead electrocardiogram
• Echocardiography
Routine care echocardiography

Locations

Country	Name	City	State
France	CHRU Nancy	Vandœuvre-lès-Nancy	CHRU De Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	F1 score for classification of cardiac contractility abnormalities		12 months