evAluation of Glycemic RangE During acutE Coronary syndroME in Nondiabetic paTients (AGREEMENT)
AGREEMENT
1 other identifier
interventional
196
1 country
1
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Mar 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 16, 2016
CompletedFirst Submitted
Initial submission to the registry
September 30, 2016
CompletedFirst Posted
Study publicly available on registry
October 13, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 25, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2017
CompletedMay 26, 2022
May 1, 2022
1 year
September 30, 2016
May 21, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (14)
Lipid profile
15 days
Lipid profile
15 days
Lipid profile
15 days
Lipid profile
15 days
Endothelial damage
15 days
- +9 more secondary outcomes
Study Arms (1)
Dysglycemic group
EXPERIMENTALPatients 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.
Interventions
This device can register blood glucose values and excursions. This device consists of a needle (applied in subcutaneous way) and of a recording device.
Eligibility Criteria
You may qualify if:
- nondiabetic patients
- acute coronary syndrome
You may not qualify if:
- diabetic patients
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Giuseppe Derosa
Pavia, 27100, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Giuseppe Derosa, MD, PhD, FESC
University of Pavia
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Masking Details
- CGMS
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD, FESC
Study Record Dates
First Submitted
September 30, 2016
First Posted
October 13, 2016
Study Start
March 16, 2016
Primary Completion
March 25, 2017
Study Completion
October 31, 2017
Last Updated
May 26, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will not share