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Heart check for diabetics: worth it or waste?

NCT ID NCT04534530

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether routine screening for heart disease is a good use of healthcare money for people with type 2 diabetes who are at very high risk but have no known heart problems. Researchers will analyze data from 90,000 patients in French health databases to compare costs and health outcomes over 4 years. The goal is to help decide if this screening should be a standard public health strategy.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 90,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2023

Expected to finish

Apr 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

40 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Hopital Haut-Leveque

    Pessac, 33600, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.