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

October 1, 2019 updated by: Universitas Negeri Semarang

Predictors of Cardiac Troponin Release After Tour de Borobudur 2017

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Actual)

94

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • Jawa Tengah
      • Semarang, Jawa Tengah, Indonesia, 50229
        • Universitas Negeri Semarang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

participants of Tour de Borobudur Indonesia 2017

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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
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
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
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiac Troponin I (cTnI)
Time Frame: immediate after TdB 2017 cycling touring within less than 5 min
specific protein to determine cardiac injury
immediate after TdB 2017 cycling touring within less than 5 min
Malondialdehyde (MDA)
Time Frame: immediate after TdB 2017 cycling touring within less than 5 min
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)
Time Frame: immediate after TdB 2017 cycling touring within less than 5 min
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
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.:

  1. 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
  2. Pathological ST-segment i.e. ST elevation (early repolarization), or another form
  3. Pathological U wave, and
  4. other pathological appearances
immediate after TdB 2017 cycling touring within less than 5 min

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitas Negeri Semarang

Collaborators

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

Investigators

  • Principal Investigator: Mahalul Azam, Dr, Universitas Negeri Semarang

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 28, 2017

Primary Completion (ACTUAL)

November 11, 2017

Study Completion (ACTUAL)

May 5, 2018

Study Registration Dates

First Submitted

October 2, 2017

First Submitted That Met QC Criteria

October 9, 2017

First Posted (ACTUAL)

October 16, 2017

Study Record Updates

Last Update Posted (ACTUAL)

October 10, 2019

Last Update Submitted That Met QC Criteria

October 1, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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