Actively Recruiting

Phase Not Applicable
Age: 18Years - 85Years
All Genders
NCT06014112

Predictive Value of Glycemic Parameters Measured With the FSL Pro iQ During ACS

Led by University Hospital, Montpellier · Updated on 2025-07-31

850

Participants Needed

9

Research Sites

234 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Disorders of glycemic regulation are common in patients hospitalized for acute coronary syndrome (ACS). Abnormal glycaemia is observed in 50% of cases, in 30-40% diabetes, and in 25-35% fasting hyperglycaemia or glucose intolerance. Hyperglycemia is a major prognostic factor in ACS, with admission hyperglycemia having independent prognostic value for both short- and long-term major cardiovascular events (MACE), regardless of the presence of diabetes. Metabolically, several situations can be distinguished: * Hyperglycaemia occurs in known non-diabetic ACS subjects. It can be indicative of (i) Type 2 Diabetes or (ii) stress hyperglycaemia (diagnostic threshold for blood sugar varies according to learned societies, with HbA1c \< 6.5%). * Hyperglycaemia occurs in known diabetic ACS subjects Most studies use admission blood sugar as a predictor. However, it has recently been shown that glycemic variability indexes would be better predictors of MACE. Using continuous glucose measurement for 48 h, it has been shown that significant glycemic variability is a more powerful predictor of MACE at 1 year than admission glycemia The measurement of glycemic variability is mainly possible thanks to the development of CGM (continuous glucose measurement). To our knowledge, no study has been interested in evaluating the predictive value of the various glycemic parameters measured by CGM. Published studies have used continuous glucose measurements for very short periods (24 or 72 hours maximum), which limits these measurements. The freestyle libre Pro iQ (FSLPro iQ) is a professional sensor for continuous, non-invasive interstitial glucose measurement allowing the recording of glycemic parameters for 2 weeks. Our hypothesis is that glycaemic parameters, alone or in combination with each other or with other patient risk factors, measured with the Freestyle libre Pro iQ have a significant prognostic value in terms of cardiovascular clinical events at 12 months in a population of patients with ACS managed as standard and followed up.

CONDITIONS

Official Title

Predictive Value of Glycemic Parameters Measured With the FSL Pro iQ During ACS

Who Can Participate

Age: 18Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with acute coronary syndrome (ACS) managed in a cardiac intensive care unit
  • Diagnosis of ACS based on chest pain with ST-segment elevation on ECG for STEMI or ST-segment changes and/or positive troponin cycle for NSTEMI
  • Age between 18 and 85 years
Not Eligible

You will not qualify if you...

  • Patients in cardiogenic or septic shock
  • Patients with ACS initially managed in a non-investigating center
  • Failure to obtain free, informed, written consent
  • Participation in another research study with an ongoing exclusion period
  • Participation in a study impacting post-ACS prognosis
  • Persons deprived of rights, under guardianship or curatorship
  • Persons deprived of liberty by judicial or administrative decision
  • Severe physical or psychological impairment affecting study compliance
  • Pregnant or breastfeeding women
  • Persons not affiliated with a social security system or beneficiaries of such a system

AI-Screening

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Trial Site Locations

Total: 9 locations

1

Hospital of Béziers

Béziers, France, 34500

Actively Recruiting

2

University Hospital of Bordeaux

Bordeaux, France, 33604

Actively Recruiting

3

University Hospital of Montpellier

Montpellier, France, 34295

Actively Recruiting

4

University Hospital of Nîmes

Nîmes, France, 30029

Actively Recruiting

5

AP-HP Lariboisière Hospital

Paris, France, 75010

Actively Recruiting

6

APHP - Hôpital Européen Georges Pompidou

Paris, France, 75015

Actively Recruiting

7

Hospital of Pau

Pau, France, 64046

Actively Recruiting

8

University Hospital of Toulouse

Toulouse, France, 31059

Actively Recruiting

9

Vannes Bretagne Atlantique Hospital

Vannes, France

Actively Recruiting

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Research Team

A

Ariane SULTAN, Professor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

PREVENTION

Number of Arms

1

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