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Predictive Value of Glycemic Parameters Measured With the FSL Pro iQ During ACS (FREESCA)

Primary Purpose

Acute Coronary Syndrome, Continuous Glucose Measurement, Glycemic Variability

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Freestyle libre Pro
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Coronary Syndrome

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients with ACS managed in a cardiac intensive care unit (ICU). The diagnosis of ACS will be made in the presence of chest pain with ST-segment elevation on the ECG for STEMI or ST-segment change and/or a positive troponin cycle (values in accordance with the center's protocol) for NSTEMI. Exclusion Criteria: Subjects in cardiogenic or septic shock Subjects with ACS initially managed in a non-investigating center Failure to obtain free, informed, written consent signed by the participant and investigator upon admission to the ICU Person participating in another research study with an ongoing exclusion period Subjects participating in a study that may have an impact on post ACS prognosis Person deprived of his or her rights, person under guardianship or curatorship Person deprived of liberty (by judicial or administrative decision) Persons whose physical and/or psychological health is severely impaired, which, in the opinion of the investigator, may affect the participant's compliance to the study Pregnant or breastfeeding women Person who is not affiliated to a social security system or who is a beneficiary of such a system.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Freestyle libre pro sensor

    No intervention

    Arm Description

    Outcomes

    Primary Outcome Measures

    Cardiovascular events
    Occurrence within 12 months of hospital discharge of a composite end point including cardiovascular clinical events: recurrent MI, cardiovascular death, stroke, rhythm disturbance, and/or heart failure requiring hospitalization.

    Secondary Outcome Measures

    Diabetes
    Incidence of diabetes at 1-2 months in nondiabetic subjects admitted for ACS: fasting venous glucose measurement (≥ 1.26g/L) and HbA1c (≥ 6.5%). Incidence of diabetes at 12 months in nondiabetic subjects admitted for ACS: measurement of fasting venous glucose (≥ 1.26g/l) and HbA1c (≥ 6.5%).

    Full Information

    First Posted
    August 22, 2023
    Last Updated
    August 22, 2023
    Sponsor
    University Hospital, Montpellier
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06014112
    Brief Title
    Predictive Value of Glycemic Parameters Measured With the FSL Pro iQ During ACS
    Acronym
    FREESCA
    Official Title
    Predictive Value of Glycemic Parameters Measured With the Freestyle Libre Pro iQ During Acute Coronary Syndrome
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 6, 2023 (Anticipated)
    Primary Completion Date
    April 5, 2026 (Anticipated)
    Study Completion Date
    April 5, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Hospital, Montpellier

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Predictive value of parameters of interstitial glucose monitoring during acute coronary syndrome

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acute Coronary Syndrome, Continuous Glucose Measurement, Glycemic Variability, Cardiovascular Event

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    852 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Freestyle libre pro sensor
    Arm Type
    Experimental
    Arm Title
    No intervention
    Arm Type
    No Intervention
    Intervention Type
    Device
    Intervention Name(s)
    Freestyle libre Pro
    Intervention Description
    Freestyle Libre Pro, is marketed by the Abbott laboratory and has a CE mark for measuring glucose levels in interstitial fluid in people with diabetes. The FSL Pro provides continuous interstitial glucose measurement using a subcutaneous sensor that produces an electrical current that varies in intensity according to the interstitial glucose level. It allows continuous measurement, without access to real-time information, with retrospective reading of the data by a health professional. The professional LSP is based on a "black box" system that accumulates the data measured by the sensor for several days. This data is then restored by downloading the system, a posteriori, thanks to a software dedicated to health professionals.
    Primary Outcome Measure Information:
    Title
    Cardiovascular events
    Description
    Occurrence within 12 months of hospital discharge of a composite end point including cardiovascular clinical events: recurrent MI, cardiovascular death, stroke, rhythm disturbance, and/or heart failure requiring hospitalization.
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    Diabetes
    Description
    Incidence of diabetes at 1-2 months in nondiabetic subjects admitted for ACS: fasting venous glucose measurement (≥ 1.26g/L) and HbA1c (≥ 6.5%). Incidence of diabetes at 12 months in nondiabetic subjects admitted for ACS: measurement of fasting venous glucose (≥ 1.26g/l) and HbA1c (≥ 6.5%).
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with ACS managed in a cardiac intensive care unit (ICU). The diagnosis of ACS will be made in the presence of chest pain with ST-segment elevation on the ECG for STEMI or ST-segment change and/or a positive troponin cycle (values in accordance with the center's protocol) for NSTEMI. Exclusion Criteria: Subjects in cardiogenic or septic shock Subjects with ACS initially managed in a non-investigating center Failure to obtain free, informed, written consent signed by the participant and investigator upon admission to the ICU Person participating in another research study with an ongoing exclusion period Subjects participating in a study that may have an impact on post ACS prognosis Person deprived of his or her rights, person under guardianship or curatorship Person deprived of liberty (by judicial or administrative decision) Persons whose physical and/or psychological health is severely impaired, which, in the opinion of the investigator, may affect the participant's compliance to the study Pregnant or breastfeeding women Person who is not affiliated to a social security system or who is a beneficiary of such a system.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ariane SULTAN, Professor
    Phone
    0467338431
    Email
    a-sultan@chu-montpellier.fr

    12. IPD Sharing Statement

    Learn more about this trial

    Predictive Value of Glycemic Parameters Measured With the FSL Pro iQ During ACS

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