TdBTS: Tour de Borobudur Troponin Study on Predictors and Synergistic Role of MDA and Hs-CRP Levels

• Sponsor: Universitas Negeri Semarang (Other)
• Overall Status: Completed
• CT.gov ID: NCT03310450
• Collaborator: Ministry of Research, Technology and Higher Education, Republic of Indonesia (Other), Universitas Diponegoro (Other)
• Enrollment: 94
• Location: 1
• Actual Duration (Months): 6.2
• Patients Per Site Per Month: 15.1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Heart Arrest; Sport Injury; Inflammatory Response; Oxidative Stress	Other: 140kms cycling

Detailed Description

Eligible Criteria:

1. minimum sample size of 80 men, non-athlete, participants of TdB

2. Classified into two groups: 160kms cycling and 100kms cycling participation

3. 25-55 years old

4. voluntary participate in the research

5. eligible in pre participatory physical examination and ECG test by the doctor

6. have no history of the previous acute coronary syndrome (ACS)

Measurements:

Interview 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

Other outcome measurements; pre and post-TdB 2017 measurements of cTnI, MDA, and hs-CRP

Study Design

• Study Type: Observational
• Actual Enrollment: 94 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Predictors of Cardiac Troponin Release After Tour de Borobudur 2017
• Actual Study Start Date: Oct 28, 2017
• Actual Primary Completion Date: Nov 11, 2017
• Actual Study Completion Date: May 5, 2018

Arms and Interventions

Arm	Intervention/Treatment
Group 140kms cycling Participants of Tour de Borobudur 2017 140 km cycling touring and willing to participate in the study. Investigator did not give any intervention, just observed the cycling touring event that the subjects participated	Other: 140kms cycling; 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); Other Names: medical history sports participation history clinical appearance lipid profile status
Group 100kms cycling Participants of Tour de Borobudur 2017 100 km cycling touring and willing to participate in the study. Investigator did not give any intervention, just observed the cycling touring event that the subjects participated	Other: 140kms cycling; 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); Other Names: medical history sports participation history clinical appearance lipid profile status
Group 240kms cycling Participants of North Coast 2017 240 km cycling touring and willing to participate in the study. Investigator did not give any intervention, just observed the cycling touring event that the subjects participated	Other: 140kms cycling; 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); Other Names: medical history sports participation history clinical appearance lipid profile status

Outcome Measures

Primary Outcome Measures

1. Cardiac Troponin I (cTnI) [immediate after TdB 2017 cycling touring within less than 5 min]

   specific protein to determine cardiac injury

2. Malondialdehyde (MDA) [immediate after TdB 2017 cycling touring within less than 5 min]

   oxydative stress marker

Secondary Outcome Measures

1. High Sensitivity C Reactive Protein (Hs-CRP) [immediate after TdB 2017 cycling touring within less than 5 min]

   a biomarker that represents the inflammation process

2. Number of Participants With Pathological ECG Appearance [immediate after TdB 2017 cycling touring within less than 5 min]

   Number of Participants with Pathological ECG Appearance. Pathological ECG appearance was the results of the ECG test describing one of the pathological appearances in ECG i.e.: 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 Pathological ST-segment i.e. ST elevation (early repolarization), or another form Pathological U wave, and other pathological appearances

Eligibility Criteria

Criteria

• Ages Eligible for Study: 25 Years to 55 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• minimum sample size of 80 men, non athlete, participants of TdB

• Classified into two groups: 160kms cycling and 100kms cycling participation

• 25-55 years old

• voluntary participate in the research

• eligible in pre participatory physical examination and ECG test by doctor have no history of previous acute coronary syndrome (ACS)

Exclusion Criteria:

• stop cycling before finish line due to mechanical or bicycle related errors

• (subjects who stop cycling due to any physical symptoms and health related problem included in analysis)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Universitas Negeri Semarang	Semarang	Jawa Tengah	Indonesia	50229

Sponsors and Collaborators

• Universitas Negeri Semarang
• Ministry of Research, Technology and Higher Education, Republic of Indonesia
• Universitas Diponegoro

Investigators

• Principal Investigator: Mahalul Azam, Dr, Universitas Negeri Semarang

Study Documents (Full-Text)

• Study Protocol - Oct 12, 2017
• Statistical Analysis Plan - Oct 12, 2017

More Information

Publications

• 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.
• 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.
• 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. Epub 2007 Apr 2. Review.
• 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.
• 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.
• 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
• 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.
• Kleinbaum DG, Kupper LL, Morgenstern H. Epidemiologic research; Principles and quantitative methods. New York: John Wiley and Son Inc; 1982. 1-527 p.
• 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. Review.
• Morrow DA. Troponins in patients with acute coronary syndromes: biologic, diagnostic, and therapeutic implications. Cardiovasc Toxicol. 2001;1(2):105-10. Review.
• 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.
• 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
• 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.
• Serrano-Ostáriz E, Legaz-Arrese A, Terreros-Blanco JL, López-Ramón M, Cremades-Arroyos D, Carranza-García 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. Erratum in: Clin J Sport Med. 2009 Sep;19(5):442. Carranza-García, Luis Enrique [added]; Alvarez-Izquierdo, Silvia [corrected to Izquierdo-Alvarez, Silvia]; Boscos-Terraz, Pilar [corrected to Bocos-Terraz, Pilar].
• Serrano-Ostáriz E, Terreros-Blanco JL, Legaz-Arrese A, George K, Shave R, Bocos-Terraz P, Izquierdo-Álvarez S, Bancalero JL, Echavarri JM, Quilez J, Aragonés MT, Carranza-García 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.
• 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.

• Responsible Party: Universitas Negeri Semarang
• ClinicalTrials.gov Identifier: NCT03310450
• Other Study ID Numbers: 0017
• First Posted: Oct 16, 2017
• Last Update Posted: Oct 10, 2019
• Last Verified: Oct 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Universitas Negeri Semarang: troponin-I; hs-CRP; Malondialdehyde; predictors
• Additional relevant MeSH terms: Heart Arrest; Athletic Injuries

Study Results

Participant Flow

Recruitment Details	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.
Pre-assignment Detail	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

Arm/Group Title	Group 140kms Cycling	Group 100kms Cycling	Group 240kms Cycling
Arm/Group 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	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	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
Period Title: Overall Study
STARTED	32	34	28
COMPLETED	30	30	28
NOT COMPLETED	2	4	0

Baseline Characteristics

Arm/Group Title	Group 140kms Cycling	Group 100kms Cycling	Group 240kms Cycling	Total
Arm/Group 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	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	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	Total of all reporting groups
Overall Participants	30	30	28	88
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	30 100%	26 86.7%	28 100%	84 95.5%
>=65 years	0 0%	4 13.3%	0 0%	4 4.5%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	43.3 (9.33)	43.5 (10.18)	49.0 (13.70)	45.3 (11.47)
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%	0 0%
Male	30 100%	30 100%	28 100%	88 100%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
Indonesia	30 100%	30 100%	28 100%	88 100%
cardiac troponin I (cTnI) (ng/dL) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [ng/dL]	5.2 (9.98)	6.6 (10.56)	3.5 (8.93)	5.2 (9.83)

Outcome Measures

1. Primary Outcome

Title	Cardiac Troponin I (cTnI)
Description	specific protein to determine cardiac injury
Time Frame	immediate after TdB 2017 cycling touring within less than 5 min

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group 140kms Cycling	Group 100kms Cycling	Group 240kms Cycling
Arm/Group 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	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	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
Measure Participants	30	30	28
Mean (Standard Deviation) [ng/dL]	6.6 (46.6)	10.1 (10.44)	25.0 (61.39)

2. Primary Outcome

Title	Malondialdehyde (MDA)
Description	oxydative stress marker
Time Frame	immediate after TdB 2017 cycling touring within less than 5 min

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group 140kms Cycling	Group 100kms Cycling	Group 240kms Cycling
Arm/Group 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	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	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
Measure Participants	30	30	28
Mean (Standard Deviation) [mcmol/mL]	206.1 (116.84)	196.4 (68.59)	231.2 (105.54)

3. Secondary Outcome

Title	High Sensitivity C Reactive Protein (Hs-CRP)
Description	a biomarker that represents the inflammation process
Time Frame	immediate after TdB 2017 cycling touring within less than 5 min

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group 140kms Cycling	Group 100kms Cycling	Group 240kms Cycling
Arm/Group 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	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	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
Measure Participants	30	30	28
Mean (Standard Deviation) [mg/dL]	454 (286.5)	335 (375.1)	350 (332.6)

4. Secondary Outcome

Title	Number of Participants With Pathological ECG Appearance
Description	Number of Participants with Pathological ECG Appearance. Pathological ECG appearance was the results of the ECG test describing one of the pathological appearances in ECG i.e.: 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 Pathological ST-segment i.e. ST elevation (early repolarization), or another form Pathological U wave, and other pathological appearances
Time Frame	immediate after TdB 2017 cycling touring within less than 5 min

Outcome Measure Data

Analysis Population Description

Pathological ECG appearance

Arm/Group Title	Group 140kms Cycling	Group 100kms Cycling	Group 240kms Cycling
Arm/Group 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	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	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
Measure Participants	30	30	28
Count of Participants [Participants]	0 0%	0 0%	0 0%

Adverse Events

Time Frame	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
Arm/Group Title	Group 140kms Cycling		Group 100kms Cycling		Group 240kms Cycling
Arm/Group 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		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		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
All Cause Mortality
	Group 140kms Cycling		Group 100kms Cycling		Group 240kms Cycling
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/30 (0%)		0/30 (0%)		0/28 (0%)
Serious Adverse Events
	Group 140kms Cycling		Group 100kms Cycling		Group 240kms Cycling
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/30 (0%)		0/30 (0%)		0/28 (0%)
Other (Not Including Serious) Adverse Events
	Group 140kms Cycling		Group 100kms Cycling		Group 240kms Cycling
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/30 (0%)		0/30 (0%)		0/28 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.