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

Acute Coronary Syndrome Clinical Trial

— AGREEMENT  

Official title:

evAluation of Glycemic RangE During acutE Coronary syndroME in Nondiabetic paTients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02932592
• Other study ID #: 20160000072
• Status: Completed
• Phase: Phase 4
• Start date: March 16, 2016
• Est. completion date: October 31, 2017

Study information

• Verified date: May 2022
• Source: University of Pavia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 196
• Est. completion date: October 31, 2017
• Est. primary completion date: March 25, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• nondiabetic patients

• acute coronary syndrome

Exclusion Criteria:

• diabetic patients

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
Italy	Giuseppe Derosa	Pavia

Sponsors (1)

Lead Sponsor	Collaborator
University of Pavia

Country where clinical trial is conducted

Italy, 

Outcome

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