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Cardiovascular Digital Health Data Observatory

Grenoble Cardiovascular Digital Health Data Observatory

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05316025
Acronym
CADHO
Enrollment
5000
Registered
2022-04-07
Start date
2022-05-31
Completion date
2025-01-31
Last updated
2022-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular, Cardiovascular Diseases, Coronarography, Digital, Health Data, Heart Failure, Observatory

Keywords

Deep learning, Observatory, Cardiovascular, Health data

Brief summary

The COVID-19 health crisis has led to a drastic decrease in the rate of myocardial infarction without the causes being completely identified. They are probably multiple, but this crisis has confirmed the need for massive health data from different horizons to better assess coronary disease in order to develop precision medicine. This objective is now achievable thanks to the use of tools such as big data and artificial intelligence (AI). Our team is developing algorithms to analyze medical images and identify people at risk of major cardiovascular events. These algorithms which are developed with retrospective data must be validated on prospective data, which is the objective of the Grenoble cardiovascular digital health data observatory. The algorithm that will be validated is currently being created as part of a RIPH 3 study AIDECORO (NCT: 04598997). It is being developed from clinical, biological and imaging data from 600 patients with ST+ infarction and 1000 control patients who have undergone coronary angiography (these data are exported and stored in the PREDIMED health data warehouse via the hospital information system).

Detailed description

This a type 3 study of the Jardé law, involving the human person, It is a study : observational study, prospective, descriptive, monocentric The main objective of the study is to prospectively validate cardiovascular medical image analysis algorithms capable of identifying patients with poor prognostic criteria using artificial intelligence and big data methods. The primary endpoint is the rate of occurrence of death or hospitalization for heart failure during follow-up. The predictive accuracy of the algorithms will be assessed by calculating the sensitivity, specificity, positive predictive value, and negative predictive value on the prospective cohort. Patients who are to undergo coronary angiography during a hospitalization in the cardiology department are prospectively recruited after obtaining their non opposition. The data were collected using the CARDIO Datamart developed by the PREDIMED health data host. The collection of the primary endpoint (death from any cause and hospitalization for heart failure) will be performed by telephone follow-up. The number of subjects needed for this study is 5000 patients. The prospective validation of the algorithm developed retrospectively in the AIDECORO project (coronary image) will make it possible to move towards the last stage of the project, which will consist of evaluating in a randomized study the superiority of precision medicine using this algorithm, allowing for therapeutic escalation or de-escalation according to the predictive risk evaluated by the algorithm in relation to usual management.

Interventions

None listed

Sponsors

University Hospital, Grenoble
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

* Adult patients who have undergone coronary angiography at CHUGA for whom images are usable. * No opposition to participation

Exclusion criteria

* Coronary image not usable * Persons referred to in articles L1121-5 to L-1121-8 of the CSP * Patients living outside the Rhône Alpes region.

Design outcomes

Primary

MeasureTime frameDescription
Prospectively validate cardiovascular medical image analysis algorithms capable of identifying patients with poor prognostic criteria using artificial intelligence and big data methods.Through study completion, an average of 1 yearThe rate of occurrence of death or hospitalization for heart failure during follow-up.

Secondary

MeasureTime frameDescription
Evaluate the predictive performance of algorithms to identify patients with persistent dyspnea symptoms.12 monthsRose Angina Questionnaire to 12 months
Evaluate the predictive performance of algorithms to identify patients with good disease perception.12 monthsSeattle Angina Questionnaire to 12 months
Evaluate the predictive performance of algorithms to identify patients satisfied with their care.12 monthsSeattle Angina Questionnaire to 12 months
Evaluate the predictive performance of algorithms to identify patients with persistent anginal symptoms.12 monthsSeattle Angina Questionnaire summary score to 12 months
Evaluate the predictive performance of algorithms for healthcare consumption12 monthsAverage annual cost of care to 12 months
Assessing the prognostic value of frailty in coronary artery diseaseDay oneDynanometry
Assessing the prognostic value of environmental influence in coronary artery diseaseDay oneMeasurement of air pollutants from the SIRANE dispersion model
Evaluate the predictive performance of the algorithms for quality of life at one year.12 monthsEuroQOL (EQ-5D-5L) to 12 months

Contacts

Primary ContactGilles Barone-Rochette
gbarone@chu-grenoble.fr0476765172
Backup ContactClémence Charlon
ccharlon@chu-grenoble.fr0476766652

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026