Predictive Value of Glycemic Parameters Measured With the Freestyle Libre Pro iQ During Acute Coronary Syndrome

Status: Recruiting
Location: See all (9) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
France
Hospital of Béziers
RECRUITING
Béziers
University Hospital of Bordeaux
RECRUITING
Bordeaux
University Hospital of Montpellier
RECRUITING
Montpellier
University Hospital of Nîmes
RECRUITING
Nîmes
AP-HP Lariboisière Hospital
RECRUITING
Paris
APHP - Hôpital Européen Georges Pompidou
RECRUITING
Paris
Hospital of Pau
RECRUITING
Pau
University Hospital of Toulouse
RECRUITING
Toulouse
Vannes Bretagne Atlantique Hospital
RECRUITING
Vannes
Contact Information
Primary
Ariane SULTAN, Professor
a-sultan@chu-montpellier.fr
0467338431
Time Frame
Start Date: 2023-11-06
Estimated Completion Date: 2028-05-06
Participants
Target number of participants: 850
Treatments
Experimental: Freestyle Libre PRO iQ sensor
Eligible patients
Sponsors
Leads: University Hospital, Montpellier

This content was sourced from clinicaltrials.gov