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

NCT03310450 | Completed Results

• 1 other identifier: 0017
• Study Type: observational
• Target: 94
• Locations: 1 country
• Sites: 1

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

Conditions

Heart Arrest; Sport Injury; Inflammatory Response; Oxidative Stress

Keywords

troponin-I; hs-CRP; Malondialdehyde; predictors

Outcome Measures

Primary Outcomes (2)

• Cardiac Troponin I (cTnI)

  specific protein to determine cardiac injury

  immediate after TdB 2017 cycling touring within less than 5 min

• Malondialdehyde (MDA)

  oxydative stress marker

  immediate after TdB 2017 cycling touring within less than 5 min

Secondary Outcomes (2)

• High Sensitivity C Reactive Protein (Hs-CRP)

  immediate after TdB 2017 cycling touring within less than 5 min

• Number of Participants With Pathological ECG Appearance

  immediate after TdB 2017 cycling touring within less than 5 min

Study Arms (3)

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

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

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

Interventions

140kms cycling OTHER

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)

Also known as: medical history, sports participation history, clinical appearance, lipid profile status

Group 100kms cycling; Group 140kms cycling; Group 240kms cycling

Eligibility Criteria

• Age: 25 Years - 55 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

participants of Tour de Borobudur Indonesia 2017

You may qualify if:

• minimum sample size of 80 men, non athlete, participants of TdB
• Classified into two groups: 160kms cycling and 100kms cycling participation
• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

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

Study Sites (1)

Universitas Negeri Semarang

Semarang, Central Java, 50229, Indonesia

Location

Related Publications (16)

• 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.

  PMID: 19919634 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 22018588 BACKGROUND

• Kleinbaum DG, Kupper LL, Morgenstern H. Epidemiologic research; Principles and quantitative methods. New York: John Wiley and Son Inc; 1982. 1-527 p.

  BACKGROUND

• 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: 21939669 BACKGROUND

• 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.

  PMID: 18929575 BACKGROUND

• 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

  BACKGROUND

• 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: 17403720 BACKGROUND

• 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: 18046180 BACKGROUND

• 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: 12213981 BACKGROUND

• 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: 19177312 BACKGROUND

• 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: 20110287 BACKGROUND

• 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: 24440407 BACKGROUND

• 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: 19638823 BACKGROUND

• 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: 20102930 BACKGROUND

• 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.

  PMID: 11835940 BACKGROUND

MeSH Terms

Conditions

Heart Arrest

Interventions

Health Records, Personal

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Medical Records; Records; Data Collection; Epidemiologic Methods; Investigative Techniques

Results Point of Contact

• Title: Mahalul Azam
• Organization: Universitas Negeri Semarang

mahalul.azam@mail.unnes.ac.id

+628122853982

Study Officials

• Mahalul Azam, Dr

  Universitas Negeri Semarang

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2017
• First Posted: October 16, 2017
• Study Start: October 28, 2017
• Primary Completion: November 11, 2017
• Study Completion: May 5, 2018
• Last Updated: October 10, 2019
• Results First Posted: October 2, 2019

Record last verified: 2019-10

Locations

ID (1)