Ignite Creation Date:
2025-12-26 @ 10:20 PM
Ignite Modification Date:
2025-12-26 @ 10:20 PM
Study NCT ID:
NCT06014112
Status:
RECRUITING
Last Update Posted:
2025-07-31
First Post:
2023-08-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Predictive Value of Glycemic Parameters Measured With the FSL Pro iQ During ACS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054058', 'term': 'Acute Coronary Syndrome'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 850}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-11-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2028-05-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-28', 'studyFirstSubmitDate': '2023-08-22', 'studyFirstSubmitQcDate': '2023-08-22', 'lastUpdatePostDateStruct': {'date': '2025-07-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-05-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cardiovascular events', 'timeFrame': '12 months', '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.'}], 'secondaryOutcomes': [{'measure': 'Diabetes', 'timeFrame': '12 months', 'description': 'Incidence of diabetes at 12 months in nondiabetic subjects admitted for ACS: measurement of fasting venous glucose (≥ 1.26g/l) and HbA1c (≥ 6.5%).'}, {'measure': 'Diabetes', 'timeFrame': '2 months', '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%).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['acute coronary syndrome', 'continuous glucose measurement', 'glycemic variability', 'cardiovascular event'], 'conditions': ['Acute Coronary Syndrome', 'Continuous Glucose Measurement', 'Glycemic Variability', 'Cardiovascular Event']}, 'descriptionModule': {'briefSummary': 'Disorders of glycemic regulation are common in patients hospitalized for acute coronary syndrome (ACS). Abnormal glycaemia is observed in 50% of cases, in 30-40% diabetes, and in 25-35% fasting hyperglycaemia or glucose intolerance.\n\nHyperglycemia is a major prognostic factor in ACS, with admission hyperglycemia having independent prognostic value for both short- and long-term major cardiovascular events (MACE), regardless of the presence of diabetes.\n\nMetabolically, several situations can be distinguished:\n\n* Hyperglycaemia occurs in known non-diabetic ACS subjects. It can be indicative of (i) Type 2 Diabetes or (ii) stress hyperglycaemia (diagnostic threshold for blood sugar varies according to learned societies, with HbA1c \\< 6.5%).\n* Hyperglycaemia occurs in known diabetic ACS subjects Most studies use admission blood sugar as a predictor. However, it has recently been shown that glycemic variability indexes would be better predictors of MACE. Using continuous glucose measurement for 48 h, it has been shown that significant glycemic variability is a more powerful predictor of MACE at 1 year than admission glycemia The measurement of glycemic variability is mainly possible thanks to the development of CGM (continuous glucose measurement).\n\nTo our knowledge, no study has been interested in evaluating the predictive value of the various glycemic parameters measured by CGM.\n\nPublished studies have used continuous glucose measurements for very short periods (24 or 72 hours maximum), which limits these measurements.\n\nThe freestyle libre Pro iQ (FSLPro iQ) is a professional sensor for continuous, non-invasive interstitial glucose measurement allowing the recording of glycemic parameters for 2 weeks.\n\nOur hypothesis is that glycaemic parameters, alone or in combination with each other or with other patient risk factors, measured with the Freestyle libre Pro iQ have a significant prognostic value in terms of cardiovascular clinical events at 12 months in a population of patients with ACS managed as standard and followed up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 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.\n\nExclusion Criteria:\n\n* Subjects in cardiogenic or septic shock\n* Subjects with ACS initially managed in a non-investigating center\n* Failure to obtain free, informed, written consent signed by the participant and investigator upon admission to the ICU\n* Person participating in another research study with an ongoing exclusion period\n* Subjects participating in a study that may have an impact on post ACS prognosis\n* Person deprived of his or her rights, person under guardianship or curatorship\n* Person deprived of liberty (by judicial or administrative decision)\n* 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\n* Pregnant or breastfeeding women\n* Person who is not affiliated to a social security system or who is a beneficiary of such a system."}, 'identificationModule': {'nctId': 'NCT06014112', 'acronym': 'FREESCA', 'briefTitle': 'Predictive Value of Glycemic Parameters Measured With the FSL Pro iQ During ACS', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': 'Predictive Value of Glycemic Parameters Measured With the Freestyle Libre Pro iQ During Acute Coronary Syndrome', 'orgStudyIdInfo': {'id': 'RECHMPL22_0395'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Freestyle Libre PRO iQ sensor', 'description': 'Eligible patients', 'interventionNames': ['Device: Freestyle Libre Pro iQ']}], 'interventions': [{'name': 'Freestyle Libre Pro iQ', 'type': 'DEVICE', 'description': 'Freestyle Libre Pro iQ is a professional sensor, marketed by the Abbott laboratory, for continuous, non-invasive interstitial glucose measurement allowing the recording of glycemic parameters for 2 weeks.\n\nThe study will be offered to any subject with an ACS. The installation of the Freestyle Libre Pro iQ sensor will be performed upon admission to intensive care Cardiology and left in place for the duration of hospitalization. In case of the Freestyle Libre Pro iQ sensor defective or removed before discharge from hospital, and if the patient tolerates it, a new the Freestyle Libre Pro iQ sensor will be placed. If the duration of hospitalization exceeds 14 days, a 2nd sensor will be placed.', 'armGroupLabels': ['Freestyle Libre PRO iQ sensor']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34500', 'city': 'Béziers', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Frédéric GEORGER, MD', 'role': 'CONTACT', 'phone': '0467357134', 'phoneExt': '33'}, {'name': 'Jean-Michel ANDRIEU, MD', 'role': 'CONTACT', 'phone': '0467357636', 'phoneExt': '33'}, {'name': 'Frédéric GEORGER', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital of Béziers', 'geoPoint': {'lat': 43.34122, 'lon': 3.21402}}, {'zip': '33604', 'city': 'Bordeaux', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Edouard GERBAUD, MD', 'role': 'CONTACT', 'email': 'edouard.gerbaud@chu-bordeaux.fr', 'phone': '0557656446', 'phoneExt': '33'}, {'name': 'CATARGI Bogdan Nicolescu, MD', 'role': 'CONTACT', 'email': 'bogdan.catargi@chu-bordeaux.fr', 'phoneExt': '33'}, {'name': 'Edouard GERBAUD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Hospital of Bordeaux', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '34295', 'city': 'Montpellier', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'François ROUBILLE, PU-PH', 'role': 'CONTACT', 'email': 'f-roubille@chu-montpellier.fr', 'phone': '0467335953', 'phoneExt': '33'}, {'name': 'Ariane SULTAN, PU-PH', 'role': 'CONTACT', 'email': 'a-sultan@chu-montpellier.fr', 'phone': '0467338402', 'phoneExt': '33'}, {'name': 'Ariane SULTAN', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'François ROUBILLE', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University Hospital of Montpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '30029', 'city': 'Nîmes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Benoît LATTUCA, Pr', 'role': 'CONTACT', 'phone': '0466683116', 'phoneExt': '33'}, {'name': 'Véronique TAILLARD, Dr', 'role': 'CONTACT', 'phone': '0466683321', 'phoneExt': '33'}, {'name': 'Benoît LATTUCA', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Hospital of Nîmes', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}, {'zip': '75010', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Patrick HENRI, Pr', 'role': 'CONTACT', 'email': 'patrick.henry@aphp.fr', 'phone': '0149959017', 'phoneExt': '33'}, {'name': 'Jean François GAUTHIER, Pr', 'role': 'CONTACT', 'email': 'jean-francois.gauthier@aphp.fr', 'phone': '0149959020'}, {'name': 'Patrick HENRI', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'AP-HP Lariboisière Hospital', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75015', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'PUYMIRAT Etienne, MD', 'role': 'CONTACT', 'email': 'etienne.puymirat@aphp.fr', 'phone': '0156092851', 'phoneExt': '33'}, {'name': 'PUYMIRAT Etienne, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'APHP - Hôpital Européen Georges Pompidou', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '64046', 'city': 'Pau', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Pierre POUSTIS, MD', 'role': 'CONTACT', 'phone': '0559924878', 'phoneExt': '33'}, {'name': 'Christel VOINOT, MD', 'role': 'CONTACT', 'phone': '0559727301', 'phoneExt': '33'}, {'name': 'Nicolas DELARCHE', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital of Pau', 'geoPoint': {'lat': 43.31117, 'lon': -0.35583}}, {'zip': '31059', 'city': 'Toulouse', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Meyer ELBAZ, Pr', 'role': 'CONTACT', 'email': 'elbaz.m@chu-toulouse.fr', 'phone': '0561323649', 'phoneExt': '33'}, {'name': 'Pierre GOURDY, Pr', 'role': 'CONTACT', 'email': 'pierre.gourdy@inserm.fr', 'phone': '0561323740', 'phoneExt': '33'}, {'name': 'Meyer ELBAZ', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Hospital of Toulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'city': 'Vannes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'HUET Fabien, MD', 'role': 'CONTACT', 'email': 'fabien.huet@ch-bretagne-atlantique.fr', 'phone': '0297416727', 'phoneExt': '33'}, {'name': 'ARNAULT Gwénaëlle, MD', 'role': 'CONTACT', 'email': 'gwenaelle.arnault@ch-bretagne-atlantique.fr'}, {'name': 'HUET Fabien, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Vannes Bretagne Atlantique Hospital', 'geoPoint': {'lat': 47.65688, 'lon': -2.76205}}], 'centralContacts': [{'name': 'Ariane SULTAN, Professor', 'role': 'CONTACT', 'email': 'a-sultan@chu-montpellier.fr', 'phone': '0467338431'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}