Ignite Creation Date:
2025-12-25 @ 2:56 AM
Ignite Modification Date:
2025-12-31 @ 7:24 AM
Study NCT ID:
NCT00926133
Status:
UNKNOWN
Last Update Posted:
2009-06-23
First Post:
2009-06-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Type 2 Diabetes and Acute Myocardial Infarction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D018149', 'term': 'Glucose Intolerance'}, {'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006943', 'term': 'Hyperglycemia'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005951', 'term': 'Glucose Tolerance Test'}], 'ancestors': [{'id': 'D001774', 'term': 'Blood Chemical Analysis'}, {'id': 'D019963', 'term': 'Clinical Chemistry Tests'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D003940', 'term': 'Diagnostic Techniques, Endocrine'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Blood samples (serum,plasma) including PaxGene tubes for mRNA sampling'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 224}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2005-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-06', 'completionDateStruct': {'date': '2009-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-06-22', 'studyFirstSubmitDate': '2009-06-22', 'studyFirstSubmitQcDate': '2009-06-22', 'lastUpdatePostDateStruct': {'date': '2009-06-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-06-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The prevalence of abnormal glucose regulation defined by an oral glucose tolerance test (OGTT).', 'timeFrame': 'Three-months after an acute ST-elevation myocardial infarction (STEMI).'}], 'secondaryOutcomes': [{'measure': 'Validate the results of an OGTT performed early after myocardial infarction,', 'timeFrame': 'Repeating the test after three months.'}, {'measure': 'Elucidate possible interactions between biomarkers of inflammation and haemostasis, and the glucometabolic status.', 'timeFrame': 'Three months'}, {'measure': 'Study the relationship between abnormal glucose regulation and prognosis after STEMI.', 'timeFrame': 'Two years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Myocardial Infarction', 'Type 2 Diabetes', 'Impaired Glucose Tolerance', 'Inflammation']}, 'referencesModule': {'references': [{'pmid': '19183453', 'type': 'RESULT', 'citation': 'Knudsen EC, Seljeflot I, Abdelnoor M, Eritsland J, Mangschau A, Arnesen H, Andersen GO. Abnormal glucose regulation in patients with acute ST- elevation myocardial infarction-a cohort study on 224 patients. Cardiovasc Diabetol. 2009 Jan 30;8:6. doi: 10.1186/1475-2840-8-6.'}, {'pmid': '31615411', 'type': 'DERIVED', 'citation': 'Helseth R, Knudsen EC, Eritsland J, Opstad TB, Arnesen H, Andersen GO, Seljeflot I. Glucose associated NETosis in patients with ST-elevation myocardial infarction: an observational study. BMC Cardiovasc Disord. 2019 Oct 15;19(1):221. doi: 10.1186/s12872-019-1205-1.'}, {'pmid': '21801387', 'type': 'DERIVED', 'citation': 'Knudsen EC, Seljeflot I, Abdelnoor M, Eritsland J, Mangschau A, Muller C, Arnesen H, Andersen GO. Impact of newly diagnosed abnormal glucose regulation on long-term prognosis in low risk patients with ST-elevation myocardial infarction: A follow-up study. BMC Endocr Disord. 2011 Jul 29;11:14. doi: 10.1186/1472-6823-11-14.'}, {'pmid': '21624046', 'type': 'DERIVED', 'citation': 'Knudsen EC, Seljeflot I, Abdelnoor M, Eritsland J, Mangschau A, Muller C, Arnesen H, Andersen GO. Elevated levels of PAI-1 activity and t-PA antigen are associated with newly diagnosed abnormal glucose regulation in patients with ST-elevation myocardial infarction. J Thromb Haemost. 2011 Aug;9(8):1468-74. doi: 10.1111/j.1538-7836.2011.04377.x.'}]}, 'descriptionModule': {'briefSummary': 'The present study was designed to determine the prevalence of previously unknown impaired glucose tolerance and type 2 diabetes in patients with acute ST-elevation myocardial infarction subjected to acute PCI. Secondary, a possible association between inflammation, haemostasis and abnormal glucose regulation was studied.', 'detailedDescription': 'Background: A high prevalence of impaired glucose tolerance (IGT) and unknown diabetes mellitus (DM) in patients with cardiovascular disease has been shown. European guidelines recommend screening of patients with AMI for DM and IGT by performing an oral glucose tolerance test (OGTT). The prevalence of IGT and DM in a Norwegian population of patients with AMI is unknown. Evidence are lacking regarding the reliability of an OGTT performed early after an AMI. The present study was designed to detect unknown IGT and DM in patients with AMI and the main challenge of the study was timing and reproducibility of the OGTT. In addition, mechanisms (inflammation, haemostasis) involved in impaired glucose regulation will be studied. Design: The study is designed as an observational cohort study prospectively including 200 patients with a primary PCI treated acute STEMI admitted to the coronary care unit at Ullevål university hospital. An OGTT is performed in-hospital and repeated after 3 months and a glucometabolic classification was performed according to the results. The patients will be followed for a minimum of two-years with regards to clinical endpoints.\n\nAims of the study:\n\n1. Study the prevalence of IGT and DM in a Norwegian population with acute STEMI.\n2. Validate the results of an OGTT performed early after myocardial infarction, by repeating the test after three months.\n3. Elucidate possible interactions between biomarkers of inflammation and coagulation, and the glucometabolic status.\n4. Study the relationship between impaired glucose tolerance and prognosis after STEMI.\n5. Contribute to an increased focus on undiagnosed DM and IGT in patients with coronary heart disease in Norway and the results may lead to an increased use of routine OGTT in the follow-up of patients with myocardial infarction. Investigate how patients with myocardial infarction and known glucometabolic state are followed up "in real-life" by their physicians.\n\nClinical implications: The study may detect a large proportion of undetected DM and IGT in patients with AMI and change present guidelines on the follow-up of patients after AMI with increased focus on impaired glucose tolerance. The study will provide new insights about the association between inflammation, haemostasis and impaired glucose tolerance in patients with acute ST-elevation myocardial infarction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with acute ST-elevation myocardial infarction without known type 2-diabetes.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with acute ST-segment elevation infarction (defined from ECG), treated with primary percutaneous coronary intervention PCI)were prospectively included.\n* Stable patients\n\nExclusion Criteria:\n\n* known DM\n* unstable patient\n* signs of heart failure\n* renal failure defined as creatinine \\>200 umol/l'}, 'identificationModule': {'nctId': 'NCT00926133', 'briefTitle': 'Type 2 Diabetes and Acute Myocardial Infarction', 'organization': {'class': 'OTHER', 'fullName': 'Ullevaal University Hospital'}, 'officialTitle': 'Impaired Glucose Tolerance in Patients With Acute Myocardial Infarction.', 'orgStudyIdInfo': {'id': 'HSØ-123'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'STEMI patients', 'description': 'Patients with acute STEMI treated by PCI without previously known type 2 diabetes.', 'interventionNames': ['Other: OGTT']}], 'interventions': [{'name': 'OGTT', 'type': 'OTHER', 'description': 'Oral glucose tolerance test (diagnostic procedure) eary after an acute STEMI and at three months follow-up.', 'armGroupLabels': ['STEMI patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '0407', 'city': 'Oslo', 'country': 'Norway', 'facility': 'Oslo University Hospital Ulleval', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}], 'overallOfficials': [{'name': 'Geir O Andersen, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Ullevaal University Hospital'}, {'name': 'Eva C Knudsen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ullevaal University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ullevaal University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Geir Oystein Andersen', 'oldOrganization': 'Ullevaal University Hospital'}}}}