Arterial HypertensionCARDINALNCT06680986
Echocardiographic Analysis by Artificial Intelligence in Hypertension
An observational study of Arterial Hypertension, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arterial Hypertension
- What is being tested?
- Clinical cardiac parameters (Arterial pressure, number of anti-hypertensive medications, and the NT-proBNP measurements)
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2022to 31 Dec 2024
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hopital Lyon Sud
Pierre-Bénite, 69310
Pierre-Yves COURAND, MD, PhD, 04.78.86.57.37 ext. +33, pierre-yves.courand@chu-lyon.fr
Pierre-Yves COURAND, MD, PhD
About this study
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.
- Conditions
- Arterial Hypertension
- Being tested
- Clinical cardiac parameters (Arterial pressure, number of anti-hypertensive medications, and the NT-proBNP measurements)
- Keywords
- Hypertension, HTN, Arterial Hypertension, Artificial Intelligence, AI, Cardiac remodelling, Left ventricular hypertrophy
- Medical subject headings
- Hypertension, Hypertrophy, Left Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical cardiac parameters (Arterial pressure, number of anti-hypertensive medications, and the NT-proBNP measurements)Other
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).
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Clinical cardiac parameters (Arterial pressure, number of anti-hypertensive medications, and the NT-proBNP measurements) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2024
- Study start1 Jun 2022
- Primary completion31 Dec 2022
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arterial HypertensionStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06680986
- Sponsor's protocol ID
- 69HCL22_0643
- Other IDs
- 898
- Acronym
- CARDINAL
- Status last verified
- Nov 2024
- First submitted
- 22 Jan 2024
- Last updated
- 8 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Echocardiographic Analysis by Artificial Intelligence in Hypertension
- ClinicalTrials.gov ID
- NCT06680986
- Acronym / sponsor ID
- CARDINAL / 69HCL22_0643
- Conditions
- Arterial Hypertension
- Keywords
- Hypertension, HTN, Arterial Hypertension, Artificial Intelligence, AI, Cardiac remodelling, Left ventricular hypertrophy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 8 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hypertensive patients | – | Other: Clinical cardiac parameters (Arterial pressure, number of anti-hypertensive medications, and the NT-proBNP measurements)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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Other | Hypertensive patients |
Primary outcome
Arterial Blood Pressure
Time frame: Baseline
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.
Number of Antihypertensive Medications
Time frame: Baseline
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)
NT-proBNP Concentration
Time frame: Baseline
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arterial Hypertension, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact PierreYves COURAND, MD ((+33) 04 78 86 57 37, pierre-yves.courand@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arterial Blood Pressure (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2024.