Ignite Creation Date:
2025-12-25 @ 2:50 AM
Ignite Modification Date:
2026-03-04 @ 10:18 PM
Study NCT ID:
NCT02111733
Status:
COMPLETED
Last Update Posted:
2014-04-11
First Post:
2013-12-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Is High Sensibility Troponins a Dialysable Marker in Hemodialysis Patients and Does it Have Prognostic Value?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051437', 'term': 'Renal Insufficiency'}], 'ancestors': [{'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 43}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-08', 'studyFirstSubmitDate': '2013-12-10', 'studyFirstSubmitQcDate': '2014-04-08', 'lastUpdatePostDateStruct': {'date': '2014-04-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-04-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'High sensibility troponins T blood level variation', 'timeFrame': '1 week', 'description': 'Verification of high sensibility troponins T blood after classical hemodialysis compared to pre-treatment levels.'}], 'secondaryOutcomes': [{'measure': 'Prognostic value of high sensibility troponins T blood level variation', 'timeFrame': 'at 6 and 12 months', 'description': 'Evaluation of a potential prognosis value of high sensibility troponins T blood levels and its variation after hemodialysis.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Renal Failure']}, 'descriptionModule': {'briefSummary': 'Evaluation of High sensibility troponin levels modification by hemodialysis in terminal renal failure patient at Sherbrooke University Hospital Center as determined by serial measurements. Verification of potential effects of these levels and their variation as predictors of cardiovascular outcomes and events at 6 and 12 months.', 'detailedDescription': 'Recruiting of hemodialysis patients of the nephrology renal supplementation clinics at Sherbrooke University Hospital Center to measure three blood level of high-sensibility troponins before and after standard dialysis. Verification on the variation of these levels after dialysis. Follow-up at 6 and 12 months of the patient for Cardiovascular events and death and verification of a possible predictive value of troponin blood levels for these events.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* over 50 years, no symptoms, over 1 months of hemodialysis\n\nExclusion Criteria:\n\n* 1 or more in the last month; Acute coronary syndrome, Heart failure decompensated, Myo or Pericarditis, Pulmonary embolism, Sepsis/shock, Stroke or transient ischemic attack, Malignant high blood pressure, Arrythmia, electrical cardio-version, major trauma, significant burnings (\\>25%), Chemotherapy, Cardiovascular surgery, percutaneous angio-intervention,\n* Chronic systemic disease (sarcoidosis, amyloidosis, LED, Etc.)'}, 'identificationModule': {'nctId': 'NCT02111733', 'acronym': 'TnT-HD', 'briefTitle': 'Is High Sensibility Troponins a Dialysable Marker in Hemodialysis Patients and Does it Have Prognostic Value?', 'organization': {'class': 'OTHER', 'fullName': 'Université de Sherbrooke'}, 'officialTitle': 'Is High Sensibility Troponins a Dialysable Marker in Hemodialysis Patients and Does it Have Prognostic Value?', 'orgStudyIdInfo': {'id': 'TnT-HD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hs-TnT', 'description': 'Hs-TNT dosage', 'interventionNames': ['Other: Hs-TNT dosage']}], 'interventions': [{'name': 'Hs-TNT dosage', 'type': 'OTHER', 'description': 'Bloodwork before and after hemodialysis for high sensibility troponins T blood level', 'armGroupLabels': ['Hs-TnT']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'J1H 5N4', 'city': 'Sherbrooke', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Centre hospitalier universitaire de Sherbrooke', 'geoPoint': {'lat': 45.40008, 'lon': -71.89908}}, {'city': 'Sherbrooke', 'state': 'Quebec', 'country': 'Canada', 'facility': 'University of Sherbrooke', 'geoPoint': {'lat': 45.40008, 'lon': -71.89908}}], 'overallOfficials': [{'name': 'Michel Nguyen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre de recherche du Centre hospitalier universitaire de Sherbrooke'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Université de Sherbrooke', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}