Trial Outcomes & Findings for Tour de Borobudur Troponin Study on Predictors and Synergistic Role of MDA and Hs-CRP Levels (NCT NCT03310450)
NCT ID: NCT03310450
Last Updated: 2019-10-10
Results Overview
specific protein to determine cardiac injury
Recruitment status
COMPLETED
Target enrollment
94 participants
Primary outcome timeframe
immediate after TdB 2017 cycling touring within less than 5 min
Results posted on
2019-10-10
Participant Flow
Consecutive sampling was done by voluntary confirmation of participants in the 2017 North Coast tour (http://ina-northcoast-cyclingtour.com/index.html) and the 2017 Tour de Borobudur (https://event.sambabikers.com/). All participants were invited to participate in this observational study via an online advertisement on the website.
Participants with a history of coronary artery diseases (CAD) were excluded from study participation. Subsequently, a total of 94 participants were included in this study
Participant milestones
| Measure |
Group 140kms Cycling
willing to participate in 140kms cycling touring of TdB 2017
140kms cycling: main exposure is long distance cycling touring (TdB/NC) consists of three groups; 140kms, 100kms and 240kms
|
Group 100kms Cycling
willing to participate in 100kms cycling touring of TdB 2017
140kms cycling: main exposure is long distance cycling touring (TdB/NC) consists of three groups; 140kms, 100kms and 240kms
|
Group 240kms Cycling
willing to participate in 240kms cycling touring of NC 2017
140kms cycling: main exposure is long distance cycling touring (TdB/NC) consists of three groups; 140kms, 100kms and 240kms
|
|---|---|---|---|
|
Overall Study
STARTED
|
32
|
34
|
28
|
|
Overall Study
COMPLETED
|
30
|
30
|
28
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Group 140kms Cycling
n=30 Participants
willing to participate in 140kms cycling touring of TdB 2017
140kms cycling: main exposure is long distance cycling touring (TdB/NC) consists of three groups; 140kms, 100kms and 240kms
|
Group 100kms Cycling
n=30 Participants
willing to participate in 100kms cycling touring of TdB 2017
140kms cycling: main exposure is long distance cycling touring (TdB/NC) consists of three groups; 140kms, 100kms and 240kms
|
Group 240kms Cycling
n=28 Participants
willing to participate in 240kms cycling touring of NC 2017
140kms cycling: main exposure is long distance cycling touring (TdB/NC) consists of three groups; 140kms, 100kms and 240kms
|
Total
n=88 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=88 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
30 Participants
n=30 Participants
|
26 Participants
n=30 Participants
|
28 Participants
n=28 Participants
|
84 Participants
n=88 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=30 Participants
|
4 Participants
n=30 Participants
|
0 Participants
n=28 Participants
|
4 Participants
n=88 Participants
|
|
Age, Continuous
|
43.3 years
STANDARD_DEVIATION 9.33 • n=30 Participants
|
43.5 years
STANDARD_DEVIATION 10.18 • n=30 Participants
|
49.0 years
STANDARD_DEVIATION 13.70 • n=28 Participants
|
45.3 years
STANDARD_DEVIATION 11.47 • n=88 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=88 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=30 Participants
|
30 Participants
n=30 Participants
|
28 Participants
n=28 Participants
|
88 Participants
n=88 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Indonesia
|
30 participants
n=30 Participants
|
30 participants
n=30 Participants
|
28 participants
n=28 Participants
|
88 participants
n=88 Participants
|
|
cardiac troponin I (cTnI)
|
5.2 ng/dL
STANDARD_DEVIATION 9.98 • n=30 Participants
|
6.6 ng/dL
STANDARD_DEVIATION 10.56 • n=30 Participants
|
3.5 ng/dL
STANDARD_DEVIATION 8.93 • n=28 Participants
|
5.2 ng/dL
STANDARD_DEVIATION 9.83 • n=88 Participants
|
PRIMARY outcome
Timeframe: immediate after TdB 2017 cycling touring within less than 5 minspecific protein to determine cardiac injury
Outcome measures
| Measure |
Group 140kms Cycling
n=30 Participants
willing to participate in 140kms cycling touring of TdB 2017
140kms cycling: main exposure is long distance cycling touring (TdB/NC) consists of three groups; 140kms, 100kms and 240kms
|
Group 100kms Cycling
n=30 Participants
willing to participate in 100kms cycling touring of TdB 2017
140kms cycling: main exposure is long distance cycling touring (TdB/NC) consists of three groups; 140kms, 100kms and 240kms
|
Group 240kms Cycling
n=28 Participants
willing to participate in 240kms cycling touring of NC 2017
140kms cycling: main exposure is long distance cycling touring (TdB/NC) consists of three groups; 140kms, 100kms and 240kms
|
|---|---|---|---|
|
Cardiac Troponin I (cTnI)
|
6.6 ng/dL
Standard Deviation 46.6
|
10.1 ng/dL
Standard Deviation 10.44
|
25.0 ng/dL
Standard Deviation 61.39
|
PRIMARY outcome
Timeframe: immediate after TdB 2017 cycling touring within less than 5 minoxydative stress marker
Outcome measures
| Measure |
Group 140kms Cycling
n=30 Participants
willing to participate in 140kms cycling touring of TdB 2017
140kms cycling: main exposure is long distance cycling touring (TdB/NC) consists of three groups; 140kms, 100kms and 240kms
|
Group 100kms Cycling
n=30 Participants
willing to participate in 100kms cycling touring of TdB 2017
140kms cycling: main exposure is long distance cycling touring (TdB/NC) consists of three groups; 140kms, 100kms and 240kms
|
Group 240kms Cycling
n=28 Participants
willing to participate in 240kms cycling touring of NC 2017
140kms cycling: main exposure is long distance cycling touring (TdB/NC) consists of three groups; 140kms, 100kms and 240kms
|
|---|---|---|---|
|
Malondialdehyde (MDA)
|
206.1 mcmol/mL
Standard Deviation 116.84
|
196.4 mcmol/mL
Standard Deviation 68.59
|
231.2 mcmol/mL
Standard Deviation 105.54
|
SECONDARY outcome
Timeframe: immediate after TdB 2017 cycling touring within less than 5 mina biomarker that represents the inflammation process
Outcome measures
| Measure |
Group 140kms Cycling
n=30 Participants
willing to participate in 140kms cycling touring of TdB 2017
140kms cycling: main exposure is long distance cycling touring (TdB/NC) consists of three groups; 140kms, 100kms and 240kms
|
Group 100kms Cycling
n=30 Participants
willing to participate in 100kms cycling touring of TdB 2017
140kms cycling: main exposure is long distance cycling touring (TdB/NC) consists of three groups; 140kms, 100kms and 240kms
|
Group 240kms Cycling
n=28 Participants
willing to participate in 240kms cycling touring of NC 2017
140kms cycling: main exposure is long distance cycling touring (TdB/NC) consists of three groups; 140kms, 100kms and 240kms
|
|---|---|---|---|
|
High Sensitivity C Reactive Protein (Hs-CRP)
|
454 mg/dL
Standard Deviation 286.5
|
335 mg/dL
Standard Deviation 375.1
|
350 mg/dL
Standard Deviation 332.6
|
SECONDARY outcome
Timeframe: immediate after TdB 2017 cycling touring within less than 5 minPopulation: 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.: 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
Outcome measures
| Measure |
Group 140kms Cycling
n=30 Participants
willing to participate in 140kms cycling touring of TdB 2017
140kms cycling: main exposure is long distance cycling touring (TdB/NC) consists of three groups; 140kms, 100kms and 240kms
|
Group 100kms Cycling
n=30 Participants
willing to participate in 100kms cycling touring of TdB 2017
140kms cycling: main exposure is long distance cycling touring (TdB/NC) consists of three groups; 140kms, 100kms and 240kms
|
Group 240kms Cycling
n=28 Participants
willing to participate in 240kms cycling touring of NC 2017
140kms cycling: main exposure is long distance cycling touring (TdB/NC) consists of three groups; 140kms, 100kms and 240kms
|
|---|---|---|---|
|
Number of Participants With Pathological ECG Appearance
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Group 140kms Cycling
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 100kms Cycling
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 240kms Cycling
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place