Ignite Creation Date:
2025-12-24 @ 4:49 PM
Ignite Modification Date:
2026-01-01 @ 8:09 AM
Study NCT ID:
NCT03310450
Status:
COMPLETED
Last Update Posted:
2019-10-10
First Post:
2017-10-02
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Tour de Borobudur Troponin Study on Predictors and Synergistic Role of MDA and Hs-CRP Levels
Sponsor:
Universitas Negeri Semarang
Organization:
Study Overview
Official Title:
Predictors of Cardiac Troponin Release After Tour de Borobudur 2017
Status:
COMPLETED
Status Verified Date:
2019-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TdBTS
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
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: