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OpenTrials
Completed

NCT Number: NCT02932592

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

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

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Key information

Conditions

Acute Coronary Syndrome Cardiovascular Diseases Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Giuseppe Derosa

Pavia, 27100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • nondiabetic patients
  • acute coronary syndrome

Exclusion criteria

  • diabetic patients

Treatment and study plan

Continuous Glucose Monitoring System (i Pro 2 - Medtronic)

Device

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Pavia

Other

Registry information

Official study title

evAluation of Glycemic RangE During acutE Coronary syndroME in Nondiabetic paTients

Acronym: AGREEMENT

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Oct 13, 2016
Registry last updated
May 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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