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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02932592
Recruitment Status : Unknown
Verified October 2016 by Giuseppe Derosa, University of Pavia.
Recruitment status was:  Recruiting
First Posted : October 13, 2016
Last Update Posted : October 13, 2016
Sponsor:
Information provided by (Responsible Party):
Giuseppe Derosa, University of Pavia

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)

Condition or disease Intervention/treatment Phase
Acute Coronary Syndrome Device: Continuous Glucose Monitoring System (i Pro 2 - Medtronic) Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: evAluation of Glycemic RangE During acutE Coronary syndroME in Nondiabetic paTients
Study Start Date : March 2016
Estimated Primary Completion Date : March 2017
Estimated Study Completion Date : October 2017

Arm Intervention/treatment
Experimental: Dysglycemic group

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)
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 Measures :
  1. Glycemic status [ Time Frame: 15 days ]

    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 :
  1. Lipid profile [ Time Frame: 15 days ]
    Total cholesterol

  2. Lipid profile [ Time Frame: 15 days ]
    HDL-cholesterol

  3. Lipid profile [ Time Frame: 15 days ]
    Triglycerides

  4. Lipid profile [ Time Frame: 15 days ]
    Lipoprotein (a)

  5. Endothelial damage [ Time Frame: 15 days ]
    sICAM-1

  6. Endothelial damage [ Time Frame: 15 days ]
    sVCAM-1

  7. Inflammation parameters [ Time Frame: 15 days ]
    sRAGE

  8. Inflammation parameters [ Time Frame: 15 days ]
    sCD40L

  9. Inflammation parameters [ Time Frame: 15 days ]
    MPO

  10. Inflammation parameters [ Time Frame: 15 days ]
    hs-CRP

  11. Inflammation parameters [ Time Frame: 15 days ]
    IL-6

  12. Inflammation parameters [ Time Frame: 15 days ]
    TNF-alfa

  13. Heart damage [ Time Frame: 15 days ]
    CPK

  14. Heart damage [ Time Frame: 15 days ]
    I troponin



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • nondiabetic patients
  • acute coronary syndrome

Exclusion Criteria:

  • diabetic patients

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02932592


Contacts
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Contact: Giuseppe Derosa, MD, PhD, FESC +39 0382 502614 giuseppe.derosa@unipv.it

Locations
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Italy
Giuseppe Derosa Recruiting
Pavia, Italy, 27100
Contact: Giuseppe Derosa, MD    +39 0382 502614    giuseppe.derosa@unipv.it   
Principal Investigator: Giuseppe Derosa, MD, PhD         
Sponsors and Collaborators
University of Pavia
Investigators
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Principal Investigator: Giuseppe Derosa, MD, PhD, FESC University of Pavia

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Responsible Party: Giuseppe Derosa, MD, PhD, FESC, University of Pavia
ClinicalTrials.gov Identifier: NCT02932592    
Other Study ID Numbers: 20160000072
First Posted: October 13, 2016    Key Record Dates
Last Update Posted: October 13, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Acute Coronary Syndrome
Syndrome
Disease
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases