Ignite Creation Date:
2024-05-06 @ 8:13 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06295081
Status:
RECRUITING
Last Update Posted:
2024-03-06
First Post:
2024-02-28
Brief Title:
TREAT Study - Improving the Interpretation of Troponin Concentrations Following Exercise and Their Clinical Significance
Sponsor:
Radboud University Medical Center
Organization:
Radboud University Medical Center
Study Overview
Official Title:
TREAT Study - Improving the Interpretation of Troponin Concentrations Following Exercise and Their Clinical Significance
Status:
RECRUITING
Status Verified Date:
2024-01
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:
TREAT
Brief Summary:
The goal of this observational study is to learn about cardiac biomarker release following exercise in amateur athletes
The main questions it aims to answer are
Question 1 What are the reference values for exercise-induced cardiac troponin elevations following walking cycling and running exercise Hypothesis 1 We hypothesize that the exercise-induced cTn release is different following walking cycling and running exercise Therefore we will establish reference values for post-exercise cTn concentrations across each of these sport types
Question 2 Is the prevalence of subclinical coronary artery disease higher in individuals with high post-exercise cardiac troponin concentrations in comparison to individuals with low post-exercise cardiac troponin concentrations Hypothesis 2 We hypothesize that athletes with the highest post-exercise cTn concentrations have a higher prevalence of coronary atherosclerosis compared to athletes matched for sex and age with the lowest post-exercise cTn concentrations
Question 3 What is the association between post-exercise cardiac troponin concentrations and major adverse cardiovascular events MACE and mortality during long-term follow-up Hypothesis 3 We hypothesize that post-exercise cTn concentrations beyond the 99th percentile are associated with an increased risk for MACE and mortality during follow-up
This study consists of three phases
Phase 1 two or three visits to the study location for amongst other measurements blood draws to assess cardiac troponin concentrations
Phase 2 CT scan of the heart in 10 of participants to assess the prevalence of subclinicial coronary artery disease
Phase 3 longitudinal follow-up to assess the incidence of major adverse cardiovascular events and mortality during 20-year follow-up
Participants will visit our study centre two three or four times
Visit 1 baseline measurements including height weight body composition and blood pressure will be obtained and a blood sample will be drawn
Visit 2 a blood sample will be drawn and activity data will be obtained from participants own sports watch or bike computer
Optional visit 3 a blood sample will be drawn Visit 4 10 of participants will undergo a cardiac CT scan to assess the prevalence of subclinical coronary artery disease
The main questions it aims to answer are
Question 1 What are the reference values for exercise-induced cardiac troponin elevations following walking cycling and running exercise Hypothesis 1 We hypothesize that the exercise-induced cTn release is different following walking cycling and running exercise Therefore we will establish reference values for post-exercise cTn concentrations across each of these sport types
Question 2 Is the prevalence of subclinical coronary artery disease higher in individuals with high post-exercise cardiac troponin concentrations in comparison to individuals with low post-exercise cardiac troponin concentrations Hypothesis 2 We hypothesize that athletes with the highest post-exercise cTn concentrations have a higher prevalence of coronary atherosclerosis compared to athletes matched for sex and age with the lowest post-exercise cTn concentrations
Question 3 What is the association between post-exercise cardiac troponin concentrations and major adverse cardiovascular events MACE and mortality during long-term follow-up Hypothesis 3 We hypothesize that post-exercise cTn concentrations beyond the 99th percentile are associated with an increased risk for MACE and mortality during follow-up
This study consists of three phases
Phase 1 two or three visits to the study location for amongst other measurements blood draws to assess cardiac troponin concentrations
Phase 2 CT scan of the heart in 10 of participants to assess the prevalence of subclinicial coronary artery disease
Phase 3 longitudinal follow-up to assess the incidence of major adverse cardiovascular events and mortality during 20-year follow-up
Participants will visit our study centre two three or four times
Visit 1 baseline measurements including height weight body composition and blood pressure will be obtained and a blood sample will be drawn
Visit 2 a blood sample will be drawn and activity data will be obtained from participants own sports watch or bike computer
Optional visit 3 a blood sample will be drawn Visit 4 10 of participants will undergo a cardiac CT scan to assess the prevalence of subclinical coronary artery disease
Detailed Description:
For a detailed description please see the attached study protocol under Documents
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 112927 | OTHER | RadboudUMC | None |