Clinical trial NCT03310450: Tour de Borobudur Troponin Study on Predictors and Synergistic Role of MDA and Hs-CRP Levels
Official title: Predictors of Cardiac Troponin Release After Tour de Borobudur 2017
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Arrest
Sport Injury
Inflammatory Response
Oxidative Stress
Keywords: troponin-I
hs-CRP
Malondialdehyde
predictors
Lead sponsor: Universitas Negeri Semarang
Sponsor class: OTHER
Collaborators: name: Ministry of Research, Technology and Higher Education, Republic of Indonesia
name: Universitas Diponegoro
First posted: 2017-10-16
Enrollment: 94
Sex: MALE
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: participants of Tour de Borobudur Indonesia 2017

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

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

Eligibility criteria: 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)

Primary outcomes:
measure: Cardiac Troponin I (cTnI)
timeFrame: immediate after TdB 2017 cycling touring within less than 5 min
measure: Malondialdehyde (MDA)
timeFrame: immediate after TdB 2017 cycling touring within less than 5 min
Secondary outcomes:
measure: High Sensitivity C Reactive Protein (Hs-CRP)
timeFrame: immediate after TdB 2017 cycling touring within less than 5 min
measure: Number of Participants With Pathological ECG Appearance
timeFrame: immediate after TdB 2017 cycling touring within less than 5 min
Other outcomes:
Locations:
city: Semarang
country: Indonesia
facility: Universitas Negeri Semarang
state: Jawa Tengah
Study officials:
affiliation: Universitas Negeri Semarang
name: Mahalul Azam, Dr
role: PRINCIPAL_INVESTIGATOR
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