Ignite Creation Date:
2025-12-26 @ 2:39 PM
Ignite Modification Date:
2026-02-25 @ 11:04 PM
Study NCT ID:
NCT03107806
Status:
TERMINATED
Last Update Posted:
2019-08-15
First Post:
2013-04-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Monitoring Glucose Levels in Patients With Myocardial Infarction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054058', 'term': 'Acute Coronary Syndrome'}, {'id': 'D006943', 'term': 'Hyperglycemia'}, {'id': 'D007003', 'term': 'Hypoglycemia'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'whyStopped': 'Blood withdrawal problems despite use of different catheters.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2018-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-14', 'studyFirstSubmitDate': '2013-04-16', 'studyFirstSubmitQcDate': '2017-04-04', 'lastUpdatePostDateStruct': {'date': '2019-08-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Accuracy of glucose values derived by the new equipment vs. standard lab recordings', 'timeFrame': 'During the first part of the study, up to 6 months', 'description': 'The above specified part of the study is ongoing. Preliminary data confirms accuracy of recorded glucose values but there is a problem with venous access over the intended time of 48 hours. A new type of venous access will be tested and ethics approval has just been accomplished.'}], 'secondaryOutcomes': [{'measure': 'Glucose variability', 'timeFrame': 'Hospitalization, through study completion, an average of 1 year', 'description': 'Glucose variability'}, {'measure': 'Number of episodes of Hypoglycemia', 'timeFrame': 'Hospitalization, through study completion, an average of 1 year', 'description': 'No of episodes of hypoglycaemia defined as glucose \\<3.0 mmol/L with or without symptoms.'}, {'measure': 'Number of episodes of Hyperglycemia', 'timeFrame': 'Hospitalization, through study completion, an average of 1 year', 'description': 'No of episodes of hyperglycemia \\>12 mmol/L'}, {'measure': 'Work load in nursing staff', 'timeFrame': 'Hospitalization, through study completion, an average of 1 year', 'description': 'Work load in nursing staff, questionnaire'}, {'measure': 'Time in targeted glucose values', 'timeFrame': 'Next step after the completion of the first and ongoing part. through study completion, an average of 1 year', 'description': 'Targets for plasma glucose are defined and the personnel will have support of the new equipment allowing continuous monitoring of glucose levels when adjusting glucose lowering therapy. This will be compared to monitoring with standard, intermittent glucose measuring.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['acute coronary syndromes', 'hyperglycemia', 'hypoglycemia', 'continuous glucose monitoring'], 'conditions': ['Acute Coronary Syndromes', 'Hyperglycemia', 'Hypoglycemia']}, 'descriptionModule': {'briefSummary': 'To evaluate the OptiScanner® for continuous glucose monitoring as a tool to optimize glucose levels in patients hospitalized for acute coronary syndromes', 'detailedDescription': 'Methodology Part a) Explorative Part b) Randomised, parallel-group design'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Acute coronary syndrome according to the joint recommendations by the European Society of Cardiology (48, 49)\n* Signed written informed consent consistent with Helsinki declaration and local legislations prior to participation in the trial.\n\nExclusion Criteria:\n\n* \\<18 years old.\n* Congestive heart failure.\n* Patients who, in the opinion of the investigator, will have difficulties to comply with the protocol (examples: alcohol or drug abuse, psychiatric disorder).'}, 'identificationModule': {'nctId': 'NCT03107806', 'acronym': 'COMGAMI', 'briefTitle': 'Monitoring Glucose Levels in Patients With Myocardial Infarction', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska Institutet'}, 'officialTitle': 'COMGAMI Continuous Monitoring of Glucose in Acute Myocardial Infarction', 'orgStudyIdInfo': {'id': '2011/1446-31/1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Glucose monitoring by OptiScanner®', 'description': 'Glucose monitoring and intervention guided by OptiScanner®', 'interventionNames': ['Device: OptiScanner®']}, {'type': 'OTHER', 'label': 'Blinded continuous glucose monitoring', 'description': 'Blinded continuous glucose monitoring by OptiScanner® and glucose lowering intervention guided by routine glucose measurements', 'interventionNames': ['Device: OptiScanner®']}], 'interventions': [{'name': 'OptiScanner®', 'type': 'DEVICE', 'description': '1. Glucose monitoring by OptiScanner® for 48 h\n2. Glucose lowering intervention (insulin) guided by OptiScanner®', 'armGroupLabels': ['Blinded continuous glucose monitoring', 'Glucose monitoring by OptiScanner®']}]}, 'contactsLocationsModule': {'locations': [{'zip': '17176', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Karolinska University hospital', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'overallOfficials': [{'name': 'Camilla Hage, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Karolinska Institutet'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lars Ryden', 'class': 'OTHER'}, 'collaborators': [{'name': 'Karolinska Institutet', 'class': 'OTHER'}, {'name': 'Swedish Heart Lung Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Senior professor', 'investigatorFullName': 'Lars Ryden', 'investigatorAffiliation': 'Karolinska Institutet'}}}}