evAluation of Glycemic RangE During acutE Coronary syndroME in Nondiabetic paTients (AGREEMENT)

Study Overview
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Brief Summary
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To evaluate the glycemic variations during acute coronary syndrome in non-diabetic patients (euglycemic, or with impaired fasting glucose, or with impaired glucose tolerance)

Detailed Description
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All nondiabetic patients with dysglycemia (fasting plasma glucose between 100 and 125 mg/dl) will be monitored with a device (Continuous Glucose Monitoring System) and all these patients will be undergone an oral glucose tolerance test after the discharge from this Unit.

Official Title
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evAluation of Glycemic RangE During acutE Coronary syndroME in Nondiabetic paTients

Conditions
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Acute Coronary Syndrome

Intervention / Treatment
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* Device: Continuous Glucose Monitoring System (i Pro 2 - Medtronic)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: nondiabetic patients acute coronary syndrome Exclusion Criteria: diabetic patients

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: CGMS
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dysglycemic group<br>Patients with dysglycemia (not diabetic patients) will be undergone a monitoring of blood glucose with a device till the discharge of the patient. Then, an oral glucose tolerance test (OGTT) will be done to categorize the patient as having impaired fasting glucose (IFG) or impaired glucose tolerance (IGT), or diabetes mellitus. | Device: Continuous Glucose Monitoring System (i Pro 2 - Medtronic)<br>* This device can register blood glucose values and excursions. This device consists of a needle (applied in subcutaneous way) and of a recording device.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycemic status | Patients with dysglycemia (not diabetic patients) will be undergone a monitoring of blood glucose with a device till the discharge of the patient. Then, an oral glucose tolerance test (OGTT) will be done to categorize the patient as having impaired fasting glucose (IFG) or impaired glucose tolerance (IGT), or diabetes mellitus. | 15 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lipid profile | Total cholesterol | 15 days | 
| Lipid profile | HDL-cholesterol | 15 days | 
| Lipid profile | Triglycerides | 15 days | 
| Lipid profile | Lipoprotein (a) | 15 days | 
| Endothelial damage | sICAM-1 | 15 days | 
| Endothelial damage | sVCAM-1 | 15 days | 
| Inflammation parameters | sRAGE | 15 days | 
| Inflammation parameters | sCD40L | 15 days | 
| Inflammation parameters | MPO | 15 days | 
| Inflammation parameters | hs-CRP | 15 days | 
| Inflammation parameters | IL-6 | 15 days | 
| Inflammation parameters | TNF-alfa | 15 days | 
| Heart damage | CPK | 15 days | 
| Heart damage | I troponin | 15 days |