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NCT03310450: TdBTS

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

Completed Results posted Last updated 10 October 2019
What this trial tests

trial testing 140kms cycling in Heart Arrest in 94 participants. Completed in 5 May 2018.

Timeline
28 October 2017
Primary endpoint
11 November 2017
5 May 2018

Quick facts

Lead sponsorUniversitas Negeri Semarang
StatusCompleted
Study typeOBSERVATIONAL
Enrollment94
Start date28 October 2017
Primary completion11 November 2017
Estimated completion5 May 2018
Sites1 location across Indonesia

Drugs / interventions tested

Conditions studied

Sponsor

Universitas Negeri Semarang — full company profile →

Who can join

Adults 25 to 55, male only, with Heart Arrest or Sport Injury. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Cardiac Troponin I (cTnI) Primary · immediate after TdB 2017 cycling touring within less than 5 min

specific protein to determine cardiac injury

GroupValue95% CI
Group 140kms Cycling6.6± 46.6
Group 100kms Cycling10.1± 10.44
Group 240kms Cycling25.0± 61.39
Malondialdehyde (MDA) Primary · immediate after TdB 2017 cycling touring within less than 5 min

oxydative stress marker

GroupValue95% CI
Group 140kms Cycling206.1± 116.84
Group 100kms Cycling196.4± 68.59
Group 240kms Cycling231.2± 105.54
High Sensitivity C Reactive Protein (Hs-CRP) Secondary · immediate after TdB 2017 cycling touring within less than 5 min

a biomarker that represents the inflammation process

GroupValue95% CI
Group 140kms Cycling454± 286.5
Group 100kms Cycling335± 375.1
Group 240kms Cycling350± 332.6
Number of Participants With Pathological ECG Appearance Secondary · 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. Pat

GroupValue95% CI
Group 140kms Cycling0
Group 100kms Cycling0
Group 240kms Cycling0

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Heart Arrest

Currently open trials in the same condition.

Other Universitas Negeri Semarang trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03310450.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing