Informations générales (source: ClinicalTrials.gov)
Predictive Value of Glycemic Parameters Measured With the Freestyle Libre Pro iQ During Acute Coronary Syndrome
Interventional
N/A
University Hospital, Montpellier (Voir sur ClinicalTrials)
novembre 2023
mai 2028
14 juin 2026
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.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP - Hôpital Europeen Georges Pompidou | PUYMIRAT Etienne, MD | Contact (sur clinicalTrials) | |||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| University Hospital of Bordeaux - 33604 - Bordeaux - France | Edouard GERBAUD, MD | Contact (sur clinicalTrials) | |||
| University Hospital of Nîmes - 30029 - Nîmes - France | Benoît LATTUCA, Pr | Contact (sur clinicalTrials) | |||
| Vannes Bretagne Atlantique Hospital - Vannes - France | HUET Fabien, MD | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| AP-HP Lariboisière Hospital - 75010 - Paris - France | Patrick HENRI, Pr | Contact (sur clinicalTrials) | |||
| Hospital of Béziers - 34500 - Béziers - France | Frédéric GEORGER, MD | Contact (sur clinicalTrials) | |||
| Hospital of Pau - 64046 - Pau - France | Pierre POUSTIS, MD | Contact (sur clinicalTrials) | |||
| University Hospital of Montpellier - 34295 - Montpellier - France | François ROUBILLE, PU-PH | Contact (sur clinicalTrials) | |||
| University Hospital of Toulouse - 31059 - Toulouse - France | Meyer ELBAZ, Pr | Contact (sur clinicalTrials) | |||
Critères
Tous
- 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.