Echocardiographic Analysis by Artificial Intelligence in Hypertension (CARDINAL)

The objective of this study is to develop artificial intelligence (AI) tools to characterize cardiac remodelling in arterial hypertension through the analysis of routine imaging data (echocardiography) coupled with patient data. More precisely, this study will make it possible (i) to represent in a relevant way the spectrum of the cardiac repercussions of a population affected by hypertension to better characterize the progress of the pathology, in particular vis-à-vis the more ambiguous subjects to be characterized ("grey" area); (ii) to develop tools for the automatic quantification of cardiac function (segmentation and robust monitoring of the myocardium during the cardiac cycle, for the dynamic analysis of the shape and global deformation of the heart) and therefore to extract descriptors richer in cardiac function than those currently used in clinical routine.

Study Overview

• Status: Recruiting
• Conditions: Arterial Hypertension
• Intervention / Treatment: Other: Clinical cardiac parameters (Arterial pressure, number of anti-hypertensive medications, and the NT-proBNP measurements)

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: PierreYves COURAND, MD; Phone Number: (+33) 04 78 86 57 37; Email: pierre-yves.courand@chu-lyon.fr
• Study Contact Backup: Name: Fatou LANGEVIN; Phone Number: (+33) 04 72 07 28 65; Email: fatou.langevin@chu-lyon.fr

Study Locations

• France
  • Pierre-Bénite, France, 69310
    • Recruiting
    • Hôpital Lyon Sud
    • Contact: Pierre-Yves COURAND, MD, PhD; Phone Number: +33 04.78.86.57.37; Email: pierre-yves.courand@chu-lyon.fr
    • Contact: Pierre-Yves COURAND, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients who underwent a comprehensive hypertension assessment during hospitalization in the Cardiologic Federation at Croix Rousse Hospital and Lyon Sud Hospital between January 2018 and December 2021

Description

Inclusion Criteria Patients who underwent a comprehensive blood pressure assessment during hospitalization in the Cardiologic Federation at Croix Rousse Hospital and Lyon Sud Hospital between January 2018 and December 2021.

Exclusion Criteria Patients who are minors. Patients under curatorship or guardianship.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Hypertensive patients; Patients having undergone a blood pressure assessment during hospitalization in the Fédération de Cardiologie at Hôpital de la Croix Rousse and Hôpital Lyon Sud from January 2018 to December 2021

Other: Clinical cardiac parameters (Arterial pressure, number of anti-hypertensive medications, and the NT-proBNP measurements); The degree of severity of the hypertension will have been previously diagnosed for each patient with the help of the blood pressure measurements, the number of antihypertensive treatments and the NT-proBNP measurement which is correlated with the left intraventricular pressure and the mass of the left ventricle. This information will be used (i) to guide the structuring of the pathology representation space during the learning phase from a sub-population (a portion of the collected database that will be used for training algorithms); (ii) to serve as an endpoint from a test sub-population (the remaining portion of the database collected).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Arterial Blood Pressure	This measure will assess the arterial blood pressure in millimeters of mercury (mmHg). Blood pressure measurements will include both systolic and diastolic values. This measurement will be used to evaluate the severity of hypertension and track changes over the course of the study.	Baseline
Number of Antihypertensive Medications	This measure will record the number of antihypertensive medications prescribed to each patient. The data will be used to assess the intensity of the treatment regimen required to control blood pressure levels in participants. Unit of Measure: Count of medications (integer)	Baseline
NT-proBNP Concentration	This measure will assess plasma concentrations of N-terminal pro b-type natriuretic peptide (NT-proBNP), a biomarker correlated with left ventricular pressure and mass. NT-proBNP levels will be analyzed in picograms per milliliter (pg/mL) to evaluate cardiac stress associated with hypertension.	Baseline

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Actual): December 31, 2022
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: January 22, 2024
• First Submitted That Met QC Criteria: November 7, 2024
• First Posted (Estimated): November 8, 2024

Study Record Updates

• Last Update Posted (Estimated): November 8, 2024
• Last Update Submitted That Met QC Criteria: November 7, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Hypertension; Artificial Intelligence; AI; Left ventricular hypertrophy; Arterial Hypertension; HTN; Cardiac remodelling
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypertension; Antihypertensive Agents
• Other Study ID Numbers: 69HCL22_0643; 898 (HCL)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No