Clinical trial NCT06014112: Predictive Value of Glycemic Parameters Measured With the FSL Pro iQ During ACS
Official title: Predictive Value of Glycemic Parameters Measured With the Freestyle Libre Pro iQ During Acute Coronary Syndrome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Coronary Syndrome
Continuous Glucose Measurement
Glycemic Variability
Cardiovascular Event
Keywords: acute coronary syndrome
continuous glucose measurement
glycemic variability
cardiovascular event
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2023-08-28
Enrollment: 850
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Patients with ACS managed in a cardiac intensive care unit (ICU). The diagnosis of ACS will be made in the presence of chest pain with ST-segment elevation on the ECG for STEMI or ST-segment change and/or a positive troponin cycle (values in accordance with the center's protocol) for NSTEMI.

Exclusion Criteria:

* Subjects in cardiogenic or septic shock
* Subjects with ACS initially managed in a non-investigating center
* Failure to obtain free, informed, written consent signed by the participant and investigator upon admission to the ICU
* Person participating in another research study with an ongoing exclusion period
* Subjects participating in a study that may have an impact on post ACS prognosis
* Person deprived of his or her rights, person under guardianship or curatorship
* Person deprived of liberty (by judicial or administrative decision)
* Persons whose physical and/or psychological health is severely impaired, which, in the opinion of the investigator, may affect the participant's compliance to the study
* Pregnant or breastfeeding women
* Person who is not affiliated to a social security system or who is a beneficiary of such a system.

Primary outcomes:
measure: Cardiovascular events
timeFrame: 12 months
Secondary outcomes:
measure: Diabetes
timeFrame: 12 months
measure: Diabetes
timeFrame: 2 months
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: University Hospital of Bordeaux
city: Béziers
country: France
facility: Hospital of Béziers
city: Montpellier
country: France
facility: University Hospital of Montpellier
city: Nîmes
country: France
facility: University Hospital of Nîmes
city: Paris
country: France
facility: AP-HP Lariboisière Hospital
city: Pau
country: France
facility: Hospital of Pau
city: Toulouse
country: France
facility: University Hospital of Toulouse
Study officials:
References: