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Completed

NCT Number: NCT03310450

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

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

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Key information

Conditions

Heart Arrest Cardiovascular Diseases Heart Diseases Inflammatory Response Oxidative Stress Sport Injury

Age range

25 year–55 year

Sex eligibility

Male

Study type

Observational

Primary location

Universitas Negeri Semarang

Semarang, Central Java, 50229, Indonesia

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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)

Other names: medical history, sports participation history, clinical appearance, lipid profile status

Primary outcomes

  1. Cardiac Troponin I (cTnI)

    Time frame: immediate after TdB 2017 cycling touring within less than 5 min

    specific protein to determine cardiac injury

  2. Malondialdehyde (MDA)

    Time frame: immediate after TdB 2017 cycling touring within less than 5 min

    oxydative stress marker

Secondary outcomes

  1. High Sensitivity C Reactive Protein (Hs-CRP)

    Time frame: 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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Universitas Negeri Semarang

Other

Collaborators

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

Registry information

Official study title

Predictors of Cardiac Troponin Release After Tour de Borobudur 2017

Acronym: TdBTS

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Oct 16, 2017
Registry last updated
Oct 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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