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

Oxidative Stress Clinical Trial

— TdBTS  

Official title:

Predictors of Cardiac Troponin Release After Tour de Borobudur 2017

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03310450
• Other study ID #: 0017
• Status: Completed
• Start date: October 28, 2017
• Est. completion date: May 5, 2018

Study information

• Verified date: October 2019
• Source: Universitas Negeri Semarang
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: May 5, 2018
• Est. primary completion date: November 11, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 25 Years to 55 Years

Eligibility

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)

Related Conditions & MeSH terms

• Athletic Injuries
• Heart Arrest
• Inflammatory Response
• Oxidative Stress
• Sport Injury

Intervention

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)

Locations

Country	Name	City	State
Indonesia	Universitas Negeri Semarang	Semarang	Jawa Tengah

Sponsors (3)

Lead Sponsor	Collaborator
Universitas Negeri Semarang	Ministry of Research, Technology and Higher Education, Republic of Indonesia, Universitas Diponegoro

Country where clinical trial is conducted

Indonesia, 

References & Publications (16)

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. — View 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. — View 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. Epub 2007 Apr 2. Review. — View 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. — View Citation

Eijsvogels TMH, Hoogerwerf MD, Maessen MFH, Seeger JPH, George KP, Hopman MTE, et al. Predictors of cardiac troponin release after a marathon. J Sci Med Sport [Internet]. 2015;18(1):88-92. Available from: http://dx.doi.org/10.1016/j.jsams.2013.12.002

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. — View Citation

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. — View Citation

Morrow DA. Troponins in patients with acute coronary syndromes: biologic, diagnostic, and therapeutic implications. Cardiovasc Toxicol. 2001;1(2):105-10. Review. — View 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. — View 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

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. — View Citation

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]. — View Citation

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. — View 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. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiac Troponin I (cTnI)	specific protein to determine cardiac injury	immediate after TdB 2017 cycling touring within less than 5 min
Primary	Malondialdehyde (MDA)	oxydative stress marker	immediate after TdB 2017 cycling touring within less than 5 min
Secondary	High Sensitivity C Reactive Protein (Hs-CRP)	a biomarker that represents the inflammation process	immediate after TdB 2017 cycling touring within less than 5 min
Secondary	Number of Participants With Pathological ECG Appearance	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	immediate after TdB 2017 cycling touring within less than 5 min