Acute Coronary SyndromePhase 4AGREEMENTNCT02932592
evAluation of Glycemic RangE During acutE Coronary syndroME in Nondiabetic paTients (AGREEMENT)
A Phase 4 study testing Continuous Glucose Monitoring System (i Pro 2 - Medtronic) in people with Acute Coronary Syndrome, run by University of Pavia at 1 site in Italy.
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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- Continuous Glucose Monitoring System (i Pro 2 - Medtronic)
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- 1 siteItaly
- Study dates
- 16 Mar 2016to 31 Oct 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- nondiabetic patients
- acute coronary syndrome
Who cannot join
- diabetic patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: evAluation of Glycemic RangE During acutE Coronary syndroME in Nondiabetic paTients
To evaluate the glycemic variations during acute coronary syndrome in non-diabetic patients (euglycemic, or with impaired fasting glucose, or with impaired glucose tolerance)
Read the 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.
- Conditions
- Acute Coronary Syndrome
- Being tested
- Continuous Glucose Monitoring System (i Pro 2 - Medtronic)
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Dysglycemic group | Experimental | 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. Receives: Device: Continuous Glucose Monitoring System (i Pro 2 - Medtronic) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 15 days
Secondary outcomes (14)
Lipid profile
Total cholesterol
Measured: 15 days
Lipid profile
HDL-cholesterol
Measured: 15 days
Lipid profile
Triglycerides
Measured: 15 days
Lipid profile
Lipoprotein (a)
Measured: 15 days
Endothelial damage
sICAM-1
Measured: 15 days
Endothelial damage
sVCAM-1
Measured: 15 days
Inflammation parameters
sRAGE
Measured: 15 days
Inflammation parameters
sCD40L
Measured: 15 days
Inflammation parameters
MPO
Measured: 15 days
Inflammation parameters
hs-CRP
Measured: 15 days
Inflammation parameters
IL-6
Measured: 15 days
Inflammation parameters
TNF-alfa
Measured: 15 days
Heart damage
CPK
Measured: 15 days
Heart damage
I troponin
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2016 (estimated)
- Study start16 Mar 2016
- Primary completion25 Mar 2017
- Study completion31 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- CGMS
- Masking
- None (open label)
- Enrolment
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giuseppe Derosa, University of Pavia
- Investigators
- Giuseppe Derosa, MD, PhD, FESC, Principal investigator, University of Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02932592
- Sponsor's protocol ID
- 20160000072
- Acronym
- AGREEMENT
- Status last verified
- May 2022
- First submitted
- 30 Sep 2016
- Last updated
- 26 May 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- evAluation of Glycemic RangE During acutE Coronary syndroME in Nondiabetic paTients
- ClinicalTrials.gov ID
- NCT02932592
- Acronym / sponsor ID
- AGREEMENT / 20160000072
- Conditions
- Acute Coronary Syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- University of PaviaUniversity, hospital or other
- Study start
- 16 Mar 2016 (actual)
- Primary completion
- 25 Mar 2017 (actual)
- Study completion
- 31 Oct 2017 (actual)
- First posted
- 13 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- CGMS
| Arm | Type | Receives |
|---|---|---|
| Dysglycemic group | Experimental | Device: Continuous Glucose Monitoring System (i Pro 2 - Medtronic)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- nondiabetic patients
- acute coronary syndrome
Key exclusion criteria (1 listed)
- diabetic patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Dysglycemic group |
Primary outcome
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.
14 secondary outcomes
Lipid profile
Time frame: 15 days
Lipid profile
Time frame: 15 days
Lipid profile
Time frame: 15 days
Lipid profile
Time frame: 15 days
Endothelial damage
Time frame: 15 days
Endothelial damage
Time frame: 15 days
Inflammation parameters
Time frame: 15 days
Inflammation parameters
Time frame: 15 days
Inflammation parameters
Time frame: 15 days
Inflammation parameters
Time frame: 15 days
Inflammation parameters
Time frame: 15 days
Inflammation parameters
Time frame: 15 days
Heart damage
Time frame: 15 days
Heart damage
Time frame: 15 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2022.
- Individual participant dataSharing planned: No
Related trials for Acute Coronary Syndrome
Recruiting
CT Stress Myocardial Perfusion, Fractional Flow Reserve and Angiography in Patients With Stable Chest Pain Syndromes
Coronary Artery Disease, Chest Syndrome
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
RecruitingPhase 4
Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
Acute Coronary Syndromes, STEMI
Recruiting
AI-Assisted Interpretation of Cardiac CT in the Emergency Department
Chest Pain, Acute Coronary Syndrome
Enrolling by invitation
Optical Coherence Tomography in Acute Vessel Evaluation
Ischemic Heart Disease, Ischemic Coronary Artery Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giuseppe Derosa, MD, PhD, FESC principal investigator
University of Pavia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Continuous Glucose Monitoring System (i Pro 2 - Medtronic) in people with Acute Coronary Syndrome, run by University of Pavia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycemic status (time frame: 15 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2022.