Ignite Creation Date:
2025-12-24 @ 4:25 PM
Ignite Modification Date:
2026-01-05 @ 3:37 AM
Study NCT ID:
NCT02572466
Status:
COMPLETED
Last Update Posted:
2016-01-29
First Post:
2015-10-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of High Sensitive Troponin-I Level in End-stage Renal Disease Patients Receiving Hemodialysis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007676', 'term': 'Kidney Failure, Chronic'}], 'ancestors': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'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'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006435', 'term': 'Renal Dialysis'}], 'ancestors': [{'id': 'D017582', 'term': 'Renal Replacement Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D016060', 'term': 'Sorption Detoxification'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'blood sample'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 207}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-27', 'studyFirstSubmitDate': '2015-10-07', 'studyFirstSubmitQcDate': '2015-10-08', 'lastUpdatePostDateStruct': {'date': '2016-01-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-10-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'High Sensitive Troponin-I in ESRD group vs Control group', 'timeFrame': '10 months', 'description': 'ESRD group\n\n* Measure the High Sensitive Troponin-I level before the hemodialysis session Control group\n* Measure the High Sensitive Troponin-I as an additional test to their follow up blood check.'}], 'secondaryOutcomes': [{'measure': 'High Sensitive Troponin-I in pre-hemodialysis vs post-hemodialysis', 'timeFrame': '4 hours', 'description': 'Measure the High Sensitive Troponin-I level before the hemodialysis session comparing to the level after the hemodialysis session.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['high-sensitive troponin-I', 'End-stage renal disease', 'hemodialysis'], 'conditions': ['End-stage Renal Disease']}, 'descriptionModule': {'briefSummary': 'This study objective is to compare the high sensitive troponin-I level in end-stage renal disease patients received hemodialysis without acute cardiovascular event with healthy population. The investigators also determine the effect of hemodialysis on troponin I level as the secondary objective.', 'detailedDescription': 'Human cardiac Troponin I (cTnI) is an composition of Troponin which is found in heart muscle cells. Molecular weight of cTnI is 23,875 Dalton consisting of 209 amino acids. \\[1,2\\] The cTnI have been used in the diagnosis of acute myocardial infarction(AMI). \\[3,4,5\\] According to ESC / ACCF / AHA / WHF, diagnosis of acute myocardial infarction rely on the data from clinical symptoms, Electrocardiogram (EKG) changes in the specific pattern, such as ST-segment elevation / depression, new left bundle branch block, and cardiac biomarker level rise over the 99th percentile upper reference limit, which makes the cTnI level was used to help in making diagnosis for patient coming with symptoms of angina in emergency room.\n\nThe current cTnI detecting test has developed more and more high sensitive(called "high-sensitive troponin-I; hsTnI") which can detected in the range 10-50,000 pg / ml (ng / L) \\[6\\], and it can detected cTnI level even in normal people unlike cTnI, which only reported positive or negative or lower than the limit of detection. Due to ARCHITECT stat High sensitive Troponin-I (Abbott diagnostic) capabilities, hsTnI level can be detected in normal people up to 96 percent.\\[7\\] The reference range of hsTnI which has been researched by Apple FS, et al.(2012) studying the 19 types of cardiac troponin I and T measurement was established. The 99th percentile values for general healthy population without hypertension, diabetes, kidney disease and myocardial infarction, aged 18-64 years was 36 ng / L in men (N = 272), 15 ng / L in women (N = 252) \\[7\\].\n\nHowever, research to find the reference of hsTnI in some groups , especially in patients with kidney disease is still limited and the diagnosis of acute myocardial infarction also use the 99th percentile as the reference source which was researched in healthy population\\[7\\] which makes it difficult to interpret. Sometimes doctors may concluded that patients with rising hsTnI because of kidney disease. According to the research in the next section, there are both support and against in this idea. Therefore, the researchers aim to study hsTnI in patients with end-stage renal disease received hemodialysis compare with normal population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'ESRD group End-stage renal disease patients receiving regular hemodialysis at King Chulalongkorn memorial hospital, Bhumirajanagarindra kidney institute hospital.\n\nControl group Patients who come to OPD at King Chulalongkorn memorial hospital for their follow up blood check.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 18 years or more.\n* was diagnosed as End-stage renal disease for more than one year.\n* Attend hemodialysis 3 times a week consistently for more than 6 months.\n* Hemodialysis with Kt/V \\> 1.2\n* No urine output or is less than 500 ml per day.\n* No symptoms of myocardial infarction Or were hospitalized with the similar diagnosis during the two weeks.\n\nExclusion Criteria:\n\n* Could not complete hemodialysis, or Kt / V \\<1.2\n* Has symptoms of myocardial infarction while receiving dialysis\n* Has the abnormal symptom (fever, chill, low BP) While receiving dialys'}, 'identificationModule': {'nctId': 'NCT02572466', 'briefTitle': 'Study of High Sensitive Troponin-I Level in End-stage Renal Disease Patients Receiving Hemodialysis', 'organization': {'class': 'OTHER', 'fullName': 'Chulalongkorn University'}, 'officialTitle': 'Study of High Sensitive Troponin-I Level in End-stage Renal Disease Patients Receiving Hemodialysis', 'orgStudyIdInfo': {'id': '271/57'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ESRD group', 'description': '1. Aged 18 years or older.\n2. was diagnosed as End-stage renal disease for more than one year.\n3. Attend hemodialysis 3 times a week consistently for more than 6 months.\n4. Hemodialysis with Kt/V \\> 1.2\n5. No urine output or is less than 500 ml per day.\n6. No symptoms of myocardial infarction Or were hospitalized with the similar diagnosis during the two weeks.', 'interventionNames': ['Other: Hemodialysis']}, {'label': 'Control group', 'description': '1. Aged 18 years or older.\n2. without kidney disease (eGFR \\> 60 ml/min/1.73m2)'}], 'interventions': [{'name': 'Hemodialysis', 'type': 'OTHER', 'description': 'ESRD group received long-term hemodialysis', 'armGroupLabels': ['ESRD group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10330', 'city': 'Bangkok', 'state': 'Bangkok', 'country': 'Thailand', 'facility': 'King Chulalongkorn Memorial Hospital', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'overallOfficials': [{'name': 'Khajohn Tiranathanagul, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chulalongkorn University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chulalongkorn University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Khajohn Tiranathanagul', 'investigatorAffiliation': 'Chulalongkorn University'}}}}