Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-26 @ 12:56 AM
Study NCT ID:
NCT03605134
Status:
TERMINATED
Last Update Posted:
2025-11-18
First Post:
2018-06-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Impact of Routine Measurement of Cardiac Troponin (hsTnT) on Outcome in Elderly Patients Undergoing Major Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Blood sample: High sensitive Troponin T'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 63}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Not enough patient recruited', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-08-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2019-08-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-14', 'studyFirstSubmitDate': '2018-06-28', 'studyFirstSubmitQcDate': '2018-07-20', 'lastUpdatePostDateStruct': {'date': '2025-11-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2018-07-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'surgical mortality', 'timeFrame': '30 days', 'description': '30 days mortality'}], 'secondaryOutcomes': [{'measure': 'diastolic function', 'timeFrame': '3 days', 'description': 'transthoracic echocardiography'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['troponin', 'diastolic function'], 'conditions': ['Surgery--Complications', 'Mortality', 'Elderly']}, 'descriptionModule': {'briefSummary': 'To document levels of cardiac troponin hsTnT in patients above 75y undergoing high risk surgery and the relationship between elevated levels and outcome in terms of hospital stay and 30 day mortality.', 'detailedDescription': 'Elevated troponin (Tn) hsTnT levels occur as a result of myocardial damage and are used in the diagnosis of myocardial infarction (MI). However, there are multiple different causes that also result in abnormal Tn levels, such as direct myocardial-cell injury, impaired renal excretion and sepsis. Because of this, elevated Tn level is a common finding in hospitalized patients.\n\nSeveral studies on patients admitted to the intensive care unit (ICU) without MI show that Tn elevation is a mortality risk factor and an independent predictor of hospital mortality.\n\nUp till now it is not yet known if the routine measurement of Tn in elderly patients undergoing surgery can significantly improve their outcome and that is the primary aim of this study. In addition, it is not known what the impact could be if a diastolic function assessment could be performed peri-operatively.\n\nThis study will examine the correlation between elevated Tn levels in elderly patients undergoing major surgery and their short-term outcome (in-hospital). Before and immediately after surgery, diastolic function will be assessed by means of transthoracic echocardiography (TTE).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '75 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All surgical patients above 75 years old', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients ≥75 y undergoing elective and major surgery till we have collected an entire dataset of 100 patients.\n* Only those patients will be included who are planned for elective and major surgery.\n\nExclusion Criteria:\n\n* Patients under the age of 75\n* Intraoperative mortality\n* Eye surgery\n* Cardiac or thoracic surgery\n* Patients undergoing surgery which is not withheld as major surgery\n* For patients undergoing multiple surgeries for the same indication and during the same hospitalization, only the first surgery will be included'}, 'identificationModule': {'nctId': 'NCT03605134', 'briefTitle': 'The Impact of Routine Measurement of Cardiac Troponin (hsTnT) on Outcome in Elderly Patients Undergoing Major Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Universitair Ziekenhuis Brussel'}, 'officialTitle': 'The Impact of Routine Measurement of Cardiac Troponin (hsTnT) on Outcome in Elderly Patients Undergoing Major Surgery', 'orgStudyIdInfo': {'id': 'Troponin'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'study group', 'description': 'level of cardiac troponin and diastolic function assessment by means of transthoracic echocardiography', 'interventionNames': ['Diagnostic Test: level of cardiac troponin', 'Diagnostic Test: diastolic function assessment']}], 'interventions': [{'name': 'level of cardiac troponin', 'type': 'DIAGNOSTIC_TEST', 'description': 'blood test', 'armGroupLabels': ['study group']}, {'name': 'diastolic function assessment', 'type': 'DIAGNOSTIC_TEST', 'description': 'transthoracic echocardiography', 'armGroupLabels': ['study group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Jette', 'state': 'Vlaams Brabant', 'country': 'Belgium', 'facility': 'Universitair Ziekenhuis Brussel', 'geoPoint': {'lat': 50.87309, 'lon': 4.33419}}], 'overallOfficials': [{'name': 'jan Poelaert, PhD, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitair Ziekenhuis Brussel'}, {'name': 'Patrice Forget, PhD, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Universitair Ziekenhuis Brussel'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitair Ziekenhuis Brussel', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}