Cardiovascular Digital Health Data Observatory (CADHO)

March 29, 2022 updated by: University Hospital, Grenoble

Grenoble Cardiovascular Digital Health Data Observatory

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).

Study Overview

Status

Not yet recruiting

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients receiving coronary angiography during hospitalization for suspected or managed coronary artery disease at CHUGA.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prospectively validate cardiovascular medical image analysis algorithms capable of identifying patients with poor prognostic criteria using artificial intelligence and big data methods.
Time Frame: Through study completion, an average of 1 year
The rate of occurrence of death or hospitalization for heart failure during follow-up.
Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the predictive performance of algorithms to identify patients with persistent anginal symptoms.
Time Frame: 12 months
Seattle Angina Questionnaire summary score to 12 months
12 months
Evaluate the predictive performance of algorithms to identify patients with persistent dyspnea symptoms.
Time Frame: 12 months
Rose Angina Questionnaire to 12 months
12 months
Evaluate the predictive performance of algorithms to identify patients with good disease perception.
Time Frame: 12 months
Seattle Angina Questionnaire to 12 months
12 months
Evaluate the predictive performance of algorithms to identify patients satisfied with their care.
Time Frame: 12 months
Seattle Angina Questionnaire to 12 months
12 months
Evaluate the predictive performance of the algorithms for quality of life at one year.
Time Frame: 12 months
EuroQOL (EQ-5D-5L) to 12 months
12 months
Evaluate the predictive performance of algorithms for healthcare consumption
Time Frame: 12 months
Average annual cost of care to 12 months
12 months
Assessing the prognostic value of frailty in coronary artery disease
Time Frame: Day one
Dynanometry
Day one
Assessing the prognostic value of environmental influence in coronary artery disease
Time Frame: Day one
Measurement of air pollutants from the SIRANE dispersion model
Day one

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Investigators

  • Principal Investigator: Gilles Barone-Rochette, Chu Grenoble Alpes

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 1, 2022

Primary Completion (Anticipated)

January 1, 2025

Study Completion (Anticipated)

January 1, 2025

Study Registration Dates

First Submitted

February 3, 2022

First Submitted That Met QC Criteria

March 29, 2022

First Posted (Actual)

April 7, 2022

Study Record Updates

Last Update Posted (Actual)

April 7, 2022

Last Update Submitted That Met QC Criteria

March 29, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 38RC21.197

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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