Back to resultsevAluation of Glycemic RangE During acutE Coronary syndroME in Nondiabetic paTients (AGREEMENT) (AGREEMENT)
Primary Purpose
Acute Coronary Syndrome
Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Continuous Glucose Monitoring System (i Pro 2 - Medtronic)
Sponsored by
About this trial
This is an interventional diagnostic trial for Acute Coronary Syndrome
Eligibility Criteria
Inclusion Criteria:
- nondiabetic patients
- acute coronary syndrome
Exclusion Criteria:
- diabetic patients
Sites / Locations
- Giuseppe Derosa
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Dysglycemic group
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Lipid profile
Total cholesterol
Lipid profile
HDL-cholesterol
Lipid profile
Triglycerides
Lipid profile
Lipoprotein (a)
Endothelial damage
sICAM-1
Endothelial damage
sVCAM-1
Inflammation parameters
sRAGE
Inflammation parameters
sCD40L
Inflammation parameters
MPO
Inflammation parameters
hs-CRP
Inflammation parameters
IL-6
Inflammation parameters
TNF-alfa
Heart damage
CPK
Heart damage
I troponin
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02932592
Brief Title
evAluation of Glycemic RangE During acutE Coronary syndroME in Nondiabetic paTients (AGREEMENT)
Acronym
AGREEMENT
Official Title
evAluation of Glycemic RangE During acutE Coronary syndroME in Nondiabetic paTients
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
March 16, 2016 (Actual)
Primary Completion Date
March 25, 2017 (Actual)
Study Completion Date
October 31, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pavia
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
CGMS
Masking
None (Open Label)
Masking Description
CGMS
Allocation
N/A
Enrollment
196 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dysglycemic group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Continuous Glucose Monitoring System (i Pro 2 - Medtronic)
Intervention Description
This device can register blood glucose values and excursions. This device consists of a needle (applied in subcutaneous way) and of a recording device.
Primary Outcome Measure Information:
Title
Glycemic status
Description
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.
Time Frame
15 days
Secondary Outcome Measure Information:
Title
Lipid profile
Description
Total cholesterol
Time Frame
15 days
Title
Lipid profile
Description
HDL-cholesterol
Time Frame
15 days
Title
Lipid profile
Description
Triglycerides
Time Frame
15 days
Title
Lipid profile
Description
Lipoprotein (a)
Time Frame
15 days
Title
Endothelial damage
Description
sICAM-1
Time Frame
15 days
Title
Endothelial damage
Description
sVCAM-1
Time Frame
15 days
Title
Inflammation parameters
Description
sRAGE
Time Frame
15 days
Title
Inflammation parameters
Description
sCD40L
Time Frame
15 days
Title
Inflammation parameters
Description
MPO
Time Frame
15 days
Title
Inflammation parameters
Description
hs-CRP
Time Frame
15 days
Title
Inflammation parameters
Description
IL-6
Time Frame
15 days
Title
Inflammation parameters
Description
TNF-alfa
Time Frame
15 days
Title
Heart damage
Description
CPK
Time Frame
15 days
Title
Heart damage
Description
I troponin
Time Frame
15 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
nondiabetic patients
acute coronary syndrome
Exclusion Criteria:
diabetic patients
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giuseppe Derosa, MD, PhD, FESC
Organizational Affiliation
University of Pavia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Giuseppe Derosa
City
Pavia
ZIP/Postal Code
27100
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
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evAluation of Glycemic RangE During acutE Coronary syndroME in Nondiabetic paTients (AGREEMENT)
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