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

Study Overview
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Brief Summary
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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

Detailed Description
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Eligible 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 the doctor 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

Official Title
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Predictors of Cardiac Troponin Release After Tour de Borobudur 2017

Conditions
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Heart Arrest, Sport Injury, Inflammatory Response, Oxidative Stress

Intervention / Treatment
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* Other: 140kms cycling


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 140kms cycling<br>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<br>* 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)<br>* Other names: lipid profile status;|
| Group 100kms cycling<br>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<br>* 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)<br>* Other names: lipid profile status;|
| Group 240kms cycling<br>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<br>* 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)<br>* Other names: lipid profile status;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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troponin-I, hs-CRP, Malondialdehyde, predictors