Does Screening of Coronary Artery Disease an Efficient Public Health Strategy in Patients With Type 2 DIABetes (SCADIAB)

December 29, 2023 updated by: University Hospital, Bordeaux

Does Screening of Coronary Artery Disease an Efficient Public Health Strategy in Patients With Type 2 DIABetes at Very High Cardiovascular Risk: Target Trial Emulation From the National Healthcare System Claims Databases in France

The purpose of SCADIAB is to assess the real-life efficiency of systematic screening for ischemic heart disease in T2DM patients at very high cardiovascular risk, without known coronary heart disease, from the databases of the National Health Data System (SNDS).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Type 2 diabetes mellitus (T2DM) is associated with an increased risk of cardiovascular and overall mortality. Cardiovascular disease is the leading cause of death, primarily ischemic heart disease, which is often early and can occur in asymptomatic diabetic patients, hence the potential benefit of routine screening to improve their cardiovascular prognosis.

There is a notable disparity between the recommendations of the french High Authority of Health (HAS) and those of learned societies. The HAS does not recommend routine screening for silent ischemic heart disease in all asymptomatic T2DM patients without known coronary heart disease, apart from a resting electrocardiogram (ECG). Functional cardiovascular examinations should be reserved for situations of high cardiovascular risk, particularly the presence of history, clinical symptoms or ECG abnormalities in favor of cardiovascular disease. On the other hand, the main learned societies of diabetology and cardiology recommend systematic screening for silent ischemic heart disease in a larger T2DM population (age> 60 years, duration of diabetes> 10 years and at least 2 cardiovascular risk factors). In terms of current clinical practice, a majority of physicians prescribe screening for silent ischemic heart disease in diabetic patients by functional examinations (stress test, myocardial tomoscintigraphy coupled with a stress test, stress echocardiography) . The investigators carried out two surveys with fellow cardiologists and diabetologists in Bordeaux and at the national level which confirm this frequent practice of screening.

The level of scientific evidence currently seems sufficient not to recommend systematic screening for silent ischemic heart disease in all diabetic patients. Four main randomized and controlled studies have not shown any benefit from this screening in terms of reducing major cardiovascular events in all T2DM patients. However, doubt remains in T2DM patients at very high cardiovascular risk, who may benefit from this strategy, but in whom no studies have been performed to date.

Study Type

Observational

Enrollment (Estimated)

90000

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

Study Contact Backup

Study Locations

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

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Among the 3.3 million people treated pharmacologically for diabetes mellitus in France, at least 3 million would be T2DM. It can be assumed that at least 2.4 million are free from coronary heart disease. This survey also shows that arterial hypertension and dyslipidemia (the two main cardiovascular risk factors) are present respectively in 58% and 57% of T2DM patients, and renal, neuropathic, or retinal complications are present respectively in 10%, 11% and 8% of them. Therefore, it can be estimated that at least 90,000 T2DM patients would be eligible (at least 2 cardiovascular risk factors and one other vascular disease) to be included in the study.

Description

Inclusion Criteria:

  • age greater than or equal to 40 years (on 2015/01/01),
  • T2DM (ALD or hospitalization for T2DM or at least 3 deliveries of at least one oral or injectable anti-diabetic drug over a year (or 2 deliveries in the event of quarterly conditioning) without ALD or hospitalization for type 1 diabetes, secondary diabetes or diabetes gestational),
  • Duration of diabetes greater than or equal to 7 years (the data available in the SNDS do not allow for an inclusion criterion of duration of diabetes> 7 years) (identified in 2008),
  • Patients with regular follow-up by a doctor (GP, cardiologist, endocrinologist) defined as having at least one contact per year (during the pre-selection period),
  • Affiliated with the general health insurance scheme,
  • With at least 2 cardiovascular risk factors: obesity (hospitalization for obesity or at least 3 deliveries of an anti-obesity drug over one year), high blood pressure (hospitalization for high blood pressure or at least 3 deliveries of at least one antihypertensive medication over one year), hypercholesterolemia (at least 3 prescriptions for statin and / or ezetimibe), or chronic obstructive pulmonary disease (used as an indicator of chronic tobacco poisoning; ALD or hospitalization for chronic obstructive pulmonary disease),
  • And presenting at least one of the following organ damage (during the pre-selection period): a) Carotid stenosis (hospitalization for carotid stenosis or act of carotid revascularization); b) AIT (ALD or hospitalization for AIT); c) Stroke (ALD or hospitalization for stroke); d) Arteriopathy obliterating of the lower limbs (ALD or hospitalization for arteriopathy obliterating of the lower limbs); e) Chronic renal disease (ALD or hospitalization for diabetic nephropathy, chronic renal failure or recourse to a technique of replacement or renal transplantation); f) Severe diabetic retinopathy treated by laser photocoagulation (ALD or hospitalization for diabetic retinopathy associated with an act of laser photocoagulation); g) Peripheral or autonomic diabetic neuropathy (ALD or hospitalization for diabetic peripheral or autonomic neuropathy),
  • Alive on 2015/01/01.

Exclusion Criteria:

  • Gestational diabetes,
  • Secondary diabetes,
  • Presence of ischemic heart disease (history or current disease): acute coronary syndrome, angina pectoris, unstable angina, or coronary revascularization,
  • Visit to an emergency department for chest pain followed by admission to an intensive care unit for cardiology,
  • Patients who have undergone one or more systematic screening examinations during the pre-selection phase.

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

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Experimental
The experimental group "systematic screening for ischemic heart disease" will be identified during the screening period by performing at least one systematic screening examination, regardless of the frequency, for ischemic heart disease in patients. diabetics at very high cardiovascular risk, without known coronary heart disease, by at least one non-invasive functional cardiovascular exploration outside the resting ECG.
Other: Systematic screening for ischemic heart disease in type 2 diabetic patients
Systematic screening for ischemic heart disease in type 2 diabetic patients at very high cardiovascular risk, without known coronary heart disease.
Control
The control group "Absence of systematic screening for ischemic heart disease" will be identified during the pre-selection period by the absence of a non-invasive functional cardiovascular exploration (examinations mentioned above) in T2D with very high cardiovascular risk, with no known coronary heart disease, apart from performing a resting ECG
Other: Systematic screening for ischemic heart disease in type 2 diabetic patients
Systematic screening for ischemic heart disease in type 2 diabetic patients at very high cardiovascular risk, without known coronary heart disease.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cost-effectiveness analysis of routine screening for ischemic heart disease in T2DM patients
Time Frame: 4 years after inclusion
The cost-effectiveness analysis is based on the differential cost per year of life gained at 4 years from the point of view of Health Insurance (SNDS).
4 years after inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cost/consequence analysis for ischemic heart disease in T2DM patients.
Time Frame: 4 years after inclusion
Direct costs (€) observed over 4 years for each strategy evaluated (screening and no screening ischemic heart disease). Based on SNDS analysis.
4 years after inclusion
Budget impact analysis for Health Insurance of the most efficient strategy
Time Frame: 4 years after inclusion
Net benefit for Health Insurance (€) from promoting the most efficient strategy: screening or no screening ischemic heart disease.
4 years after inclusion

Collaborators and Investigators

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

Sponsor

University Hospital, Bordeaux

Investigators

  • Study Chair: Julien BEZIN, Dr, University Hospital, Bordeaux
  • Study Chair: Antoine BENARD, Dr, USMR

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 (Actual)

June 5, 2023

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

January 1, 2025

Study Registration Dates

First Submitted

August 26, 2020

First Submitted That Met QC Criteria

August 31, 2020

First Posted (Actual)

September 1, 2020

Study Record Updates

Last Update Posted (Estimated)

January 3, 2024

Last Update Submitted That Met QC Criteria

December 29, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUBX 2019/68

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

Clinical Trials on Diabetes Mellitus, Type 2

Clinical Trials on Systematic screening for ischemic heart disease in type 2 diabetic patients

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Sweden

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe