The primary aim of this explorative study is to compare exercise-induced cardiac troponin elevations between athletes with different levels of coronary atherosclerosis. The secondary aim is to compare exercise responses to other cardiac biomarkers…
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome is cardiac troponin concentration at 0/30/60/120 and 180
minutes after exercise cessation.
Secondary outcome
Secondary endpoints are other cardiac biomarkers (B-type natriuretic peptide,
soluble ST-2, cardiac myosin-binding protein C and Galectin-3) collected at the
same timepoints. Furthermore, exercise-specific physiological parameters
(including blood pressure, saturation and heart rate), biochemical biomarkers
(calcium, parathyroid hormone, phosphate and magnesium) and measures of
vascular function (Carotid Artery Reactivity test) are collected to gain more
insight into the potential underlying mechanisms of accelerated coronary
atherosclerosis in amateur athletes.
Background summary
Presence of coronary atherosclerosis is associated with an increased
cardiovascular risk. An increased prevalence and severity of coronary
atherosclerosis is reported among athletes compared to less active controls,
suggesting an exercise-dose dependent relationship. Nevertheless, athletes were
asymptomatic and had no abnormalities on sports medical examination. Recent
studies have reported that post-exercise troponin concentrations above the 99th
percentile are predictive of adverse cardiovascular outcomes. High
post-exercise troponin concentrations may therefore be indicative of
subclinical cardiovascular disease, such as coronary atherosclerosis. No
studies have been performed to investigate this association. We hypothesize
that athletes with the most severe coronary atherosclerosis show an exaggerated
exercise-induced cardiac biomarker elevation compared to athletes without
coronary atherosclerosis. This could possibly imply a novel screening
instrument for coronary atherosclerosis.
Study objective
The primary aim of this explorative study is to compare exercise-induced
cardiac troponin elevations between athletes with different levels of coronary
atherosclerosis. The secondary aim is to compare exercise responses to other
cardiac biomarkers across subgroups, whereas physiological and biochemical
responses are assessed to gain more insight in the potential underlying
mechanisms of accelerated coronary atherosclerosis in amateur athletes.
Study design
An observational cohort explorative study
Study burden and risks
Participants will visit the Radboudumc once for an exercise test on a
stationary bike. The burden of the exercise test is low, since all participants
are amateur athletes and accustomed to regular exercise training. For safety
reasons, a physician will be present during the exercise test. The test can be
aborted when termination criteria are met or if the participants decide so (8,
9). Blood will be drawn from an intravenous cannula, which may occasionally
(<5%) result in a hematoma. Participants may experience transient pallor,
dizziness, weakness or sweating following the blood draw of 20ml per time point
(140 ml in total). These symptoms generally disappear rapidly. The carotid
artery reactivity test will cause temporal discomfort due to the 3-minute
submersion of a hand in ice water, but any discomfort will quickly alleviate
after the test and no lasting effects will occur. Taken together, the burden
and risks of the present study can be considered as negligible.
Oude Molenweg 235
Nijmegen 6532BA
NL
Oude Molenweg 235
Nijmegen 6532BA
NL
Listed location countries
Age
Inclusion criteria
- Participation in MARC-2 study (so recent information about coronary
atherosclerosis is known).
- Availability of recent (<2 years) contrast enhanced coronary CT-scan data
- Willingness to be approached for participation in future research (as
indicated on the informed consent form of the MARC-2 study)
- Able to perform a ±1.5 hour exercise test on a bicycle
Exclusion criteria
- Unable to give informed consent
- Presence of a stent in any coronary artery or undergone coronary artery
bypass surgery
- Not cleared for exercise training by a cardiologist following the MARC-2
study coronary CT-scan findings
- Absolute contra-indications for an exercise test (as indicated by the
Standard Operating Procedure guidelines of the department of Physiology (see
page 16 of C1 protocol)).
- Participation in an interventional study targeting cardiovascular health
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL74326.091.20 |
| OMON | NL-OMON24615 |