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

NCT ID: NCT02932592

Last Updated: 2022-05-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

196 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-16

Study Completion Date

2017-10-31

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.

Conditions

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Acute Coronary Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

CGMS
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

CGMS

Study Groups

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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.

Group Type EXPERIMENTAL

Continuous Glucose Monitoring System (i Pro 2 - Medtronic)

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* nondiabetic patients
* acute coronary syndrome

Exclusion Criteria

* diabetic patients
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Pavia

OTHER

Sponsor Role lead

Responsible Party

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Giuseppe Derosa

MD, PhD, FESC

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Giuseppe Derosa, MD, PhD, FESC

Role: PRINCIPAL_INVESTIGATOR

University of Pavia

Locations

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Giuseppe Derosa

Pavia, , Italy

Site Status

Countries

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Italy

Other Identifiers

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20160000072

Identifier Type: -

Identifier Source: org_study_id

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