Ignite Creation Date:
2025-12-25 @ 3:04 AM
Ignite Modification Date:
2025-12-26 @ 1:43 AM
Study NCT ID:
NCT01102933
Status:
COMPLETED
Last Update Posted:
2014-03-26
First Post:
2010-04-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
RElevance of Biomarkers for Future Risk of Thromboembolic Events in UnSelected Post-myocardial Infarction Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009203', 'term': 'Myocardial Infarction'}], '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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood samples will be collected for analysis of biomarkers and platelets. At the first visit after the hospital stay blood for DNA analysis will also be collected.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 425}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'completionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-03-22', 'studyFirstSubmitDate': '2010-04-12', 'studyFirstSubmitQcDate': '2010-04-12', 'lastUpdatePostDateStruct': {'date': '2014-03-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-04-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Death, myocardial infarction, stroke', 'timeFrame': 'Five years from study start', 'description': 'Death: Death will be sub-classified by vascular or non-vascular primary cause. All deaths with unknown/uncertain cause will be categorized as vascular death.\n\nMyocardial Infarction(MI): Rehospitalization due to new non fatal MI or development of significant Q-wave.\n\nStroke: Diagnosed as abrupt onset of focal neurological deficit persisting more than 24 hours.'}], 'secondaryOutcomes': [{'measure': 'Venous thromboembolism, Arterial embolism, Bleeding', 'timeFrame': 'Five years from study start', 'description': 'Venous thromboembolism: Deep venous thrombosis has to be diagnosed by ultrasonography or venography. Pulmonary embolism has to be diagnosed by spiral CT scan, pulmonary angiogram or ventilation-perfusion scanning.\n\nArterial embolism: Diagnosed as an arterial event. Radiological evidence includes imaging studies.\n\nBleedings: Classified as major or minor using International Society on Thrombosis and Haemostasis (ISTH). Major bleeds will be diagnosed as fatal and/or symptomatic bleeding in critical area or organ and/or bleeding associated with a decrease in Hb of 20 g/L or more or leading to transfusion.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Myocardial Infarction']}, 'descriptionModule': {'briefSummary': 'The study is an open, single center, observational study at the Cardiology Dept at Uppsala University Hospital. The number of patients included will be 410. The objectives are to:\n\nEvaluate biomarkers and change of these related to myocardial infarction, during two years follow-up in an unselected patient population with a recent myocardial infarction.\n\nEvaluate if an early change of biomarkers can be related to death, new myocardial infarction, and ischemic stroke in the same population after two and five years follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients diagnosed wilth myocardial infarction and hospitalized at the Cardiology Department, Uppsala University Hospital, the study population will be unselected.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Myocardial infarction diagnosed by dynamic raised troponin I with at least one value above 0.1 µg/L. Together with at least one of the criteria; symptoms suggestive for myocardial infarction or development of significant Q wave.\n2. Treated at the Department of cardiology, Uppsala University Hospital.\n3. Ability to attend the scheduled visits for evaluation procedures.\n4. Signed Informed Consent.\n\nExclusion Criteria:\n\n1. Death ≤ 5 days after the myocardial infarction.\n2. Not belonging to the catchment area of Uppsala University Hospital.\n3. Lack of suitability for participation in the trial, for any reason, as judged by the Investigator.'}, 'identificationModule': {'nctId': 'NCT01102933', 'acronym': 'REBUS', 'briefTitle': 'RElevance of Biomarkers for Future Risk of Thromboembolic Events in UnSelected Post-myocardial Infarction Patients', 'organization': {'class': 'OTHER', 'fullName': 'Uppsala University'}, 'officialTitle': 'RElevance of Biomarkers for Future Risk of Thromboembolic Events in UnSelected Post-myocardial Infarction Patients - an Observational Study (REBUS)', 'orgStudyIdInfo': {'id': 'U-09-003'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Unselected post-myocard infarct patients', 'description': 'Patients diagnosed with MI at Uppsala University Hospital'}]}, 'contactsLocationsModule': {'locations': [{'zip': '751 85', 'city': 'Uppsal University Hospital', 'state': 'Uppsala County', 'country': 'Sweden', 'facility': 'Cardiology Department'}], 'overallOfficials': [{'name': 'Christina Christersson, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cardiology Department, Uppsala University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Uppsala University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}