Ignite Creation Date:
2025-12-24 @ 4:49 PM
Ignite Modification Date:
2026-01-31 @ 3:08 PM
Study NCT ID:
NCT03310450
Status:
COMPLETED
Last Update Posted:
2019-10-10
First Post:
2017-10-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Tour de Borobudur Troponin Study on Predictors and Synergistic Role of MDA and Hs-CRP Levels
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006323', 'term': 'Heart Arrest'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D055991', 'term': 'Health Records, Personal'}], 'ancestors': [{'id': 'D008499', 'term': 'Medical Records'}, {'id': 'D011996', 'term': 'Records'}, {'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mahalul.azam@mail.unnes.ac.id', 'phone': '+628122853982', 'title': 'Mahalul Azam', 'organization': 'Universitas Negeri Semarang'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'during the event (cycling activity of TdB and NC) i.e. 6.1 hours range 3.5-9.8 and 24 hours after the event', 'eventGroups': [{'id': 'EG000', 'title': 'Group 140kms Cycling', 'description': 'willing to participate in 140kms cycling touring of TdB 2017\n\n140kms cycling: main exposure is long distance cycling touring (TdB/NC) consists of three groups; 140kms, 100kms and 240kms', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Group 100kms Cycling', 'description': 'willing to participate in 100kms cycling touring of TdB 2017\n\n140kms cycling: main exposure is long distance cycling touring (TdB/NC) consists of three groups; 140kms, 100kms and 240kms', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Group 240kms Cycling', 'description': 'willing to participate in 240kms cycling touring of NC 2017\n\n140kms cycling: main exposure is long distance cycling touring (TdB/NC) consists of three groups; 140kms, 100kms and 240kms', 'otherNumAtRisk': 28, 'deathsNumAtRisk': 28, 'otherNumAffected': 0, 'seriousNumAtRisk': 28, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Cardiac Troponin I (cTnI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 140kms Cycling', 'description': 'willing to participate in 140kms cycling touring of TdB 2017\n\n140kms cycling: main exposure is long distance cycling touring (TdB/NC) consists of three groups; 140kms, 100kms and 240kms'}, {'id': 'OG001', 'title': 'Group 100kms Cycling', 'description': 'willing to participate in 100kms cycling touring of TdB 2017\n\n140kms cycling: main exposure is long distance cycling touring (TdB/NC) consists of three groups; 140kms, 100kms and 240kms'}, {'id': 'OG002', 'title': 'Group 240kms Cycling', 'description': 'willing to participate in 240kms cycling touring of NC 2017\n\n140kms cycling: main exposure is long distance cycling touring (TdB/NC) consists of three groups; 140kms, 100kms and 240kms'}], 'classes': [{'categories': [{'measurements': [{'value': '6.6', 'spread': '46.6', 'groupId': 'OG000'}, {'value': '10.1', 'spread': '10.44', 'groupId': 'OG001'}, {'value': '25.0', 'spread': '61.39', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'immediate after TdB 2017 cycling touring within less than 5 min', 'description': 'specific protein to determine cardiac injury', 'unitOfMeasure': 'ng/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Malondialdehyde (MDA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 140kms Cycling', 'description': 'willing to participate in 140kms cycling touring of TdB 2017\n\n140kms cycling: main exposure is long distance cycling touring (TdB/NC) consists of three groups; 140kms, 100kms and 240kms'}, {'id': 'OG001', 'title': 'Group 100kms Cycling', 'description': 'willing to participate in 100kms cycling touring of TdB 2017\n\n140kms cycling: main exposure is long distance cycling touring (TdB/NC) consists of three groups; 140kms, 100kms and 240kms'}, {'id': 'OG002', 'title': 'Group 240kms Cycling', 'description': 'willing to participate in 240kms cycling touring of NC 2017\n\n140kms cycling: main exposure is long distance cycling touring (TdB/NC) consists of three groups; 140kms, 100kms and 240kms'}], 'classes': [{'categories': [{'measurements': [{'value': '206.1', 'spread': '116.84', 'groupId': 'OG000'}, {'value': '196.4', 'spread': '68.59', 'groupId': 'OG001'}, {'value': '231.2', 'spread': '105.54', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'immediate after TdB 2017 cycling touring within less than 5 min', 'description': 'oxydative stress marker', 'unitOfMeasure': 'mcmol/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'High Sensitivity C Reactive Protein (Hs-CRP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 140kms Cycling', 'description': 'willing to participate in 140kms cycling touring of TdB 2017\n\n140kms cycling: main exposure is long distance cycling touring (TdB/NC) consists of three groups; 140kms, 100kms and 240kms'}, {'id': 'OG001', 'title': 'Group 100kms Cycling', 'description': 'willing to participate in 100kms cycling touring of TdB 2017\n\n140kms cycling: main exposure is long distance cycling touring (TdB/NC) consists of three groups; 140kms, 100kms and 240kms'}, {'id': 'OG002', 'title': 'Group 240kms Cycling', 'description': 'willing to participate in 240kms cycling touring of NC 2017\n\n140kms cycling: main exposure is long distance cycling touring (TdB/NC) consists of three groups; 140kms, 100kms and 240kms'}], 'classes': [{'categories': [{'measurements': [{'value': '454', 'spread': '286.5', 'groupId': 'OG000'}, {'value': '335', 'spread': '375.1', 'groupId': 'OG001'}, {'value': '350', 'spread': '332.6', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'immediate after TdB 2017 cycling touring within less than 5 min', 'description': 'a biomarker that represents the inflammation process', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Pathological ECG Appearance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 140kms Cycling', 'description': 'willing to participate in 140kms cycling touring of TdB 2017 140kms cycling: main exposure is long distance cycling touring (TdB/NC) consists of three groups; 140kms, 100kms and 240kms'}, {'id': 'OG001', 'title': 'Group 100kms Cycling', 'description': 'willing to participate in 100kms cycling touring of TdB 2017 140kms cycling: main exposure is long distance cycling touring (TdB/NC) consists of three groups; 140kms, 100kms and 240kms'}, {'id': 'OG002', 'title': 'Group 240kms Cycling', 'description': 'willing to participate in 240kms cycling touring of NC 2017 140kms cycling: main exposure is long distance cycling touring (TdB/NC) consists of three groups; 140kms, 100kms and 240kms'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'immediate after TdB 2017 cycling touring within less than 5 min', 'description': 'Number of Participants with Pathological ECG Appearance.\n\nPathological ECG appearance was the results of the ECG test describing one of the pathological appearances in ECG i.e.:\n\n1. The pathological rhythm which is may consist of Atrial Flutter, Atrial Fibrillation, Supraventricular Tachycardia, Ventricular Fibrillation, First Degree Heart Block, Second Degree Heart Block, Type 1 - Mobitz I, Second Degree Heart Block, Type 2 - Mobitz II, Third Degree Heart Block, or other pathological rhythm appearances\n2. Pathological ST-segment i.e. ST elevation (early repolarization), or another form\n3. Pathological U wave, and\n4. other pathological appearances', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Pathological ECG appearance'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group 140kms Cycling', 'description': 'willing to participate in 140kms cycling touring of TdB 2017\n\n140kms cycling: main exposure is long distance cycling touring (TdB/NC) consists of three groups; 140kms, 100kms and 240kms'}, {'id': 'FG001', 'title': 'Group 100kms Cycling', 'description': 'willing to participate in 100kms cycling touring of TdB 2017\n\n140kms cycling: main exposure is long distance cycling touring (TdB/NC) consists of three groups; 140kms, 100kms and 240kms'}, {'id': 'FG002', 'title': 'Group 240kms Cycling', 'description': 'willing to participate in 240kms cycling touring of NC 2017\n\n140kms cycling: main exposure is long distance cycling touring (TdB/NC) consists of three groups; 140kms, 100kms and 240kms'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '34'}, {'groupId': 'FG002', 'numSubjects': '28'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '30'}, {'groupId': 'FG002', 'numSubjects': '28'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Consecutive sampling was done by voluntary confirmation of participants in the 2017 North Coast tour (http://ina-northcoast-cyclingtour.com/index.html) and the 2017 Tour de Borobudur (https://event.sambabikers.com/). All participants were invited to participate in this observational study via an online advertisement on the website.', 'preAssignmentDetails': 'Participants with a history of coronary artery diseases (CAD) were excluded from study participation. Subsequently, a total of 94 participants were included in this study'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '88', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Group 140kms Cycling', 'description': 'willing to participate in 140kms cycling touring of TdB 2017\n\n140kms cycling: main exposure is long distance cycling touring (TdB/NC) consists of three groups; 140kms, 100kms and 240kms'}, {'id': 'BG001', 'title': 'Group 100kms Cycling', 'description': 'willing to participate in 100kms cycling touring of TdB 2017\n\n140kms cycling: main exposure is long distance cycling touring (TdB/NC) consists of three groups; 140kms, 100kms and 240kms'}, {'id': 'BG002', 'title': 'Group 240kms Cycling', 'description': 'willing to participate in 240kms cycling touring of NC 2017\n\n140kms cycling: main exposure is long distance cycling touring (TdB/NC) consists of three groups; 140kms, 100kms and 240kms'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '88', 'groupId': 'BG003'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '84', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '88', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '43.3', 'spread': '9.33', 'groupId': 'BG000'}, {'value': '43.5', 'spread': '10.18', 'groupId': 'BG001'}, {'value': '49.0', 'spread': '13.70', 'groupId': 'BG002'}, {'value': '45.3', 'spread': '11.47', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '88', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '88', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Indonesia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '88', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '88', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'cardiac troponin I (cTnI)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '88', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '5.2', 'spread': '9.98', 'groupId': 'BG000'}, {'value': '6.6', 'spread': '10.56', 'groupId': 'BG001'}, {'value': '3.5', 'spread': '8.93', 'groupId': 'BG002'}, {'value': '5.2', 'spread': '9.83', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'ng/dL', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': '30 participants completed Tour de Borobudur 140K, 2017 30 participants completed Tour de Borobudur 100K, 2017 28 participantas completed North Coast Tour, 2017'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-10-12', 'size': 141632, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-02-20T11:09', 'hasProtocol': True}, {'date': '2017-10-12', 'size': 116211, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-02-20T11:10', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 94}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2018-05-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-01', 'studyFirstSubmitDate': '2017-10-02', 'resultsFirstSubmitDate': '2018-07-30', 'studyFirstSubmitQcDate': '2017-10-09', 'lastUpdatePostDateStruct': {'date': '2019-10-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-09-05', 'studyFirstPostDateStruct': {'date': '2017-10-16', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2019-10-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-11-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cardiac Troponin I (cTnI)', 'timeFrame': 'immediate after TdB 2017 cycling touring within less than 5 min', 'description': 'specific protein to determine cardiac injury'}, {'measure': 'Malondialdehyde (MDA)', 'timeFrame': 'immediate after TdB 2017 cycling touring within less than 5 min', 'description': 'oxydative stress marker'}], 'secondaryOutcomes': [{'measure': 'High Sensitivity C Reactive Protein (Hs-CRP)', 'timeFrame': 'immediate after TdB 2017 cycling touring within less than 5 min', 'description': 'a biomarker that represents the inflammation process'}, {'measure': 'Number of Participants With Pathological ECG Appearance', 'timeFrame': 'immediate after TdB 2017 cycling touring within less than 5 min', 'description': 'Number of Participants with Pathological ECG Appearance.\n\nPathological ECG appearance was the results of the ECG test describing one of the pathological appearances in ECG i.e.:\n\n1. The pathological rhythm which is may consist of Atrial Flutter, Atrial Fibrillation, Supraventricular Tachycardia, Ventricular Fibrillation, First Degree Heart Block, Second Degree Heart Block, Type 1 - Mobitz I, Second Degree Heart Block, Type 2 - Mobitz II, Third Degree Heart Block, or other pathological rhythm appearances\n2. Pathological ST-segment i.e. ST elevation (early repolarization), or another form\n3. Pathological U wave, and\n4. other pathological appearances'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['troponin-I', 'hs-CRP', 'Malondialdehyde', 'predictors'], 'conditions': ['Heart Arrest', 'Sport Injury', 'Inflammatory Response', 'Oxidative Stress']}, 'referencesModule': {'references': [{'pmid': '19919634', 'type': 'BACKGROUND', 'citation': 'Serrano-Ostariz E, Terreros-Blanco JL, Legaz-Arrese A, George K, Shave R, Bocos-Terraz P, Izquierdo-Alvarez S, Bancalero JL, Echavarri JM, Quilez J, Aragones MT, Carranza-Garcia LE. The impact of exercise duration and intensity on the release of cardiac biomarkers. Scand J Med Sci Sports. 2011 Apr;21(2):244-9. doi: 10.1111/j.1600-0838.2009.01042.x.'}, {'type': 'BACKGROUND', 'citation': 'Grande G, Romppel M, Glaesmer H, Petrowski K, Herrmann-Lingen C. The type-D scale (DS14) - Norms and prevalence of type-D personality in a population-based representative sample in Germany. Pers Individ Dif [Internet]. 2010;48(8):935-9. Available from: http://dx.doi.org/10.1016/j.paid.2010.02.026'}, {'pmid': '22018588', 'type': 'BACKGROUND', 'citation': 'Lee PH, Macfarlane DJ, Lam TH, Stewart SM. Validity of the International Physical Activity Questionnaire Short Form (IPAQ-SF): a systematic review. Int J Behav Nutr Phys Act. 2011 Oct 21;8:115. doi: 10.1186/1479-5868-8-115.'}, {'type': 'BACKGROUND', 'citation': 'Kleinbaum DG, Kupper LL, Morgenstern H. Epidemiologic research; Principles and quantitative methods. New York: John Wiley and Son Inc; 1982. 1-527 p.'}, {'pmid': '21939669', 'type': 'BACKGROUND', 'citation': 'Bahrudin U, Morikawa K, Takeuchi A, Kurata Y, Miake J, Mizuta E, Adachi K, Higaki K, Yamamoto Y, Shirayoshi Y, Yoshida A, Kato M, Yamamoto K, Nanba E, Morisaki H, Morisaki T, Matsuoka S, Ninomiya H, Hisatome I. Impairment of ubiquitin-proteasome system by E334K cMyBPC modifies channel proteins, leading to electrophysiological dysfunction. J Mol Biol. 2011 Nov 4;413(4):857-78. doi: 10.1016/j.jmb.2011.09.006. Epub 2011 Sep 12.'}, {'pmid': '18929575', 'type': 'BACKGROUND', 'citation': 'Bahrudin U, Morisaki H, Morisaki T, Ninomiya H, Higaki K, Nanba E, Igawa O, Takashima S, Mizuta E, Miake J, Yamamoto Y, Shirayoshi Y, Kitakaze M, Carrier L, Hisatome I. Ubiquitin-proteasome system impairment caused by a missense cardiac myosin-binding protein C mutation and associated with cardiac dysfunction in hypertrophic cardiomyopathy. J Mol Biol. 2008 Dec 26;384(4):896-907. doi: 10.1016/j.jmb.2008.09.070. Epub 2008 Oct 7.'}, {'type': 'BACKGROUND', 'citation': 'Purwowiyoto SL, Aryadi A, Suryaatmadja B, Ruray D, Purwowiyoto BS, Siswanto BB. Positive correlation between ECG dispersion mapping (heartvueTM) with T2DM patients. Glob Heart [Internet]. 2014;9(1):e243. Available from: http://linkinghub.elsevier.com/retrieve/pii/S221181601402119X'}, {'pmid': '17403720', 'type': 'BACKGROUND', 'citation': 'de Koning L, Merchant AT, Pogue J, Anand SS. Waist circumference and waist-to-hip ratio as predictors of cardiovascular events: meta-regression analysis of prospective studies. Eur Heart J. 2007 Apr;28(7):850-6. doi: 10.1093/eurheartj/ehm026. Epub 2007 Apr 2.'}, {'pmid': '18046180', 'type': 'BACKGROUND', 'citation': 'Shave R, George KP, Atkinson G, Hart E, Middleton N, Whyte G, Gaze D, Collinson PO. Exercise-induced cardiac troponin T release: a meta-analysis. Med Sci Sports Exerc. 2007 Dec;39(12):2099-106. doi: 10.1249/mss.0b013e318153ff78.'}, {'pmid': '12213981', 'type': 'BACKGROUND', 'citation': 'Morrow DA. Troponins in patients with acute coronary syndromes: biologic, diagnostic, and therapeutic implications. Cardiovasc Toxicol. 2001;1(2):105-10. doi: 10.1385/ct:1:2:105.'}, {'pmid': '19177312', 'type': 'BACKGROUND', 'citation': 'Jassal DS, Moffat D, Krahn J, Ahmadie R, Fang T, Eschun G, Sharma S. Cardiac injury markers in non-elite marathon runners. Int J Sports Med. 2009 Feb;30(2):75-9. doi: 10.1055/s-0028-1104572. Epub 2009 Jan 28.'}, {'pmid': '20110287', 'type': 'BACKGROUND', 'citation': 'Rodondi N, Marques-Vidal P, Butler J, Sutton-Tyrrell K, Cornuz J, Satterfield S, Harris T, Bauer DC, Ferrucci L, Vittinghoff E, Newman AB; Health, Aging, and Body Composition Study. Markers of atherosclerosis and inflammation for prediction of coronary heart disease in older adults. Am J Epidemiol. 2010 Mar 1;171(5):540-9. doi: 10.1093/aje/kwp428. Epub 2010 Jan 28.'}, {'pmid': '24440407', 'type': 'BACKGROUND', 'citation': 'Eijsvogels TM, Hoogerwerf MD, Maessen MF, Seeger JP, George KP, Hopman MT, Thijssen DH. Predictors of cardiac troponin release after a marathon. J Sci Med Sport. 2015 Jan;18(1):88-92. doi: 10.1016/j.jsams.2013.12.002. Epub 2014 Jan 2.'}, {'pmid': '19638823', 'type': 'BACKGROUND', 'citation': 'Serrano-Ostariz E, Legaz-Arrese A, Terreros-Blanco JL, Lopez-Ramon M, Cremades-Arroyos D, Carranza-Garcia LE, Izquierdo-Alvarez S, Bocos-Terraz P. Cardiac biomarkers and exercise duration and intensity during a cycle-touring event. Clin J Sport Med. 2009 Jul;19(4):293-9. doi: 10.1097/JSM.0b013e3181ab3c9d.'}, {'pmid': '20102930', 'type': 'BACKGROUND', 'citation': 'Eijsvogels T, George K, Shave R, Gaze D, Levine BD, Hopman MT, Thijssen DH. Effect of prolonged walking on cardiac troponin levels. Am J Cardiol. 2010 Jan 15;105(2):267-72. doi: 10.1016/j.amjcard.2009.08.679.'}, {'pmid': '11835940', 'type': 'BACKGROUND', 'citation': 'Neumayr G, Pfister R, Mitterbauer G, Maurer A, Gaenzer H, Sturm W, Hoertnagl H. Effect of the "Race Across The Alps" in elite cyclists on plasma cardiac troponins I and T. Am J Cardiol. 2002 Feb 15;89(4):484-6. doi: 10.1016/s0002-9149(01)02280-9. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'Prospective observational study to determine predictors that related to cardiac troponin I (cTnI) release, malondialdehyde (MDA) and high sensitivity C Reactive Protein (hs-CRP) after Tour de Borobudur (TdB) 2017', 'detailedDescription': 'Eligible Criteria:\n\n1. minimum sample size of 80 men, non-athlete, participants of TdB\n2. Classified into two groups: 160kms cycling and 100kms cycling participation\n3. 25-55 years old\n4. voluntary participate in the research\n5. eligible in pre participatory physical examination and ECG test by the doctor\n6. have no history of the previous acute coronary syndrome (ACS)\n\nMeasurements:\n\nInterview for determining predictors of sports participation history, medical history, family medical history and Rate of Perceived Exertion Measurement and examination to determine: anthropometry parameters, clinical conditions (Systolic BP, Diastolic BP, hemoglobin levels, T-cholesterol and HDL-C levels, the intensity in cycling activities (mileage, velocity, duration, and time for resting), hemodynamic responses (average and maximum heart rate, Karvonen Index), and Hydration status\n\nOther outcome measurements; pre and post-TdB 2017 measurements of cTnI, MDA, and hs-CRP'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '25 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'participants of Tour de Borobudur Indonesia 2017', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* minimum sample size of 80 men, non athlete, participants of TdB\n* Classified into two groups: 160kms cycling and 100kms cycling participation\n* 25-55 years old\n* voluntary participate in the research\n* eligible in pre participatory physical examination and ECG test by doctor have no history of previous acute coronary syndrome (ACS)\n\nExclusion Criteria:\n\n* stop cycling before finish line due to mechanical or bicycle related errors\n* (subjects who stop cycling due to any physical symptoms and health related problem included in analysis)'}, 'identificationModule': {'nctId': 'NCT03310450', 'acronym': 'TdBTS', 'briefTitle': 'Tour de Borobudur Troponin Study on Predictors and Synergistic Role of MDA and Hs-CRP Levels', 'organization': {'class': 'OTHER', 'fullName': 'Universitas Negeri Semarang'}, 'officialTitle': 'Predictors of Cardiac Troponin Release After Tour de Borobudur 2017', 'orgStudyIdInfo': {'id': '0017'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 140kms cycling', 'description': 'Participants of Tour de Borobudur 2017 140 km cycling touring and willing to participate in the study.\n\nInvestigator did not give any intervention, just observed the cycling touring event that the subjects participated', 'interventionNames': ['Other: 140kms cycling']}, {'label': 'Group 100kms cycling', 'description': 'Participants of Tour de Borobudur 2017 100 km cycling touring and willing to participate in the study.\n\nInvestigator did not give any intervention, just observed the cycling touring event that the subjects participated', 'interventionNames': ['Other: 140kms cycling']}, {'label': 'Group 240kms cycling', 'description': 'Participants of North Coast 2017 240 km cycling touring and willing to participate in the study.\n\nInvestigator did not give any intervention, just observed the cycling touring event that the subjects participated', 'interventionNames': ['Other: 140kms cycling']}], 'interventions': [{'name': '140kms cycling', 'type': 'OTHER', 'otherNames': ['medical history', 'sports participation history', 'clinical appearance', 'lipid profile status'], 'description': 'Main exposure is long distance cycling touring (TdB/NC) consists of three groups; 140kms, 100kms, and 240kms (investigator did not give any treatment/intervention, just observed the cycling touring event)', 'armGroupLabels': ['Group 100kms cycling', 'Group 140kms cycling', 'Group 240kms cycling']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50229', 'city': 'Semarang', 'state': 'Central Java', 'country': 'Indonesia', 'facility': 'Universitas Negeri Semarang', 'geoPoint': {'lat': -6.99306, 'lon': 110.42083}}], 'overallOfficials': [{'name': 'Mahalul Azam, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitas Negeri Semarang'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitas Negeri Semarang', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministry of Research, Technology and Higher Education, Republic of Indonesia', 'class': 'UNKNOWN'}, {'name': 'Universitas Diponegoro', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}