NCT04534530

Brief Summary

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).

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 26, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 1, 2020

Completed
2.8 years until next milestone

Study Start

First participant enrolled

June 5, 2023

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

January 15, 2026

Status Verified

January 1, 2026

Enrollment Period

2.8 years

First QC Date

August 26, 2020

Last Update Submit

January 13, 2026

Conditions

Diabetes Mellitus, Type 2

Keywords

cost / efficiency ratioFrench health data baseIschemic heart disease

Outcome Measures

Primary Outcomes (1)

  • Cost-effectiveness analysis of routine screening for ischemic heart disease in T2DM patients

    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 Outcomes (2)

  • Cost/consequence analysis for ischemic heart disease in T2DM patients.

    4 years after inclusion

  • Budget impact analysis for Health Insurance of the most efficient strategy

    4 years after inclusion

Study Arms (2)

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

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

Interventions

Systematic screening for ischemic heart disease in type 2 diabetic patientsOTHER

Systematic screening for ischemic heart disease in type 2 diabetic patients at very high cardiovascular risk, without known coronary heart disease.

ControlExperimental

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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),
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Haut-Leveque

Pessac, 33600, France

Location

Related Publications (1)

  • Mohammedi K, Preaubert N, Cariou T, Rigalleau V, Foussard N, Piazza L, Bairras-Martin C, Couffinhal T, Bezin J, Benard A. Cost-effectiveness of screening of coronary artery disease in patients with type 2 DIABetes at a very high cardiovascular risk (SCADIAB study) rational and design. Cardiovasc Diabetol. 2021 Mar 13;20(1):63. doi: 10.1186/s12933-021-01253-2.

    PMID: 33714278DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Myocardial Ischemia

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Julien BEZIN, Dr

    University Hospital, Bordeaux

    STUDY CHAIR

  • Antoine BENARD, Dr

    USMR

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 26, 2020

First Posted

September 1, 2020

Study Start

June 5, 2023

Primary Completion

April 1, 2026

Study Completion

April 1, 2026

Last Updated

January 15, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)