Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2022-A02826-37 | Other Identifier | IDRCB |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Freestyle Libre PRO iQ sensor | Experimental | Eligible patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Freestyle Libre Pro iQ | Device | Freestyle Libre Pro iQ is a professional sensor, marketed by the Abbott laboratory, for continuous, non-invasive interstitial glucose measurement allowing the recording of glycemic parameters for 2 weeks. The study will be offered to any subject with an ACS. The installation of the Freestyle Libre Pro iQ sensor will be performed upon admission to intensive care Cardiology and left in place for the duration of hospitalization. In case of the Freestyle Libre Pro iQ sensor defective or removed before discharge from hospital, and if the patient tolerates it, a new the Freestyle Libre Pro iQ sensor will be placed. If the duration of hospitalization exceeds 14 days, a 2nd sensor will be placed. |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiovascular events | Occurrence within 12 months of hospital discharge of a composite end point including cardiovascular clinical events: recurrent MI, cardiovascular death, stroke, rhythm disturbance, and/or heart failure requiring hospitalization. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Diabetes | Incidence of diabetes at 12 months in nondiabetic subjects admitted for ACS: measurement of fasting venous glucose (≥ 1.26g/l) and HbA1c (≥ 6.5%). | 12 months |
| Diabetes | Incidence of diabetes at 1-2 months in nondiabetic subjects admitted for ACS: fasting venous glucose measurement (≥ 1.26g/L) and HbA1c (≥ 6.5%). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ariane SULTAN, Professor | Contact | 0467338431 | a-sultan@chu-montpellier.fr |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital of Béziers | Recruiting | Béziers | 34500 | France |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 2 months |
| University Hospital of Bordeaux | Recruiting | Bordeaux | 33604 | France |
|
| University Hospital of Montpellier | Recruiting | Montpellier | 34295 | France |
|
| University Hospital of Nîmes | Recruiting | Nîmes | 30029 | France |
|
| AP-HP Lariboisière Hospital | Recruiting | Paris | 75010 | France |
|
| APHP - Hôpital Européen Georges Pompidou | Recruiting | Paris | 75015 | France |
|
| Hospital of Pau | Recruiting | Pau | 64046 | France |
|
| University Hospital of Toulouse | Recruiting | Toulouse | 31059 | France |
|
| Vannes Bretagne Atlantique Hospital | Recruiting | Vannes | France |
|
| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
Not provided
Not provided