Primary aim: To establish reference values for exercise-induced elevations of cTn concentrations following walking, cycling and running exercise. Secondary aim: Assess the prevalence of (sub)clinical coronary artery disease in individuals with high…
ID
Source
Brief title
Condition
- Other condition
- Coronary artery disorders
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Health condition
hart- en vaatziekten
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Baseline and post-exercise concentrations of high-sensitivity cTn I (hs-cTnI)
and T (hs-cTnT) will be established for our primary aim.
Secondary outcome
Subsequently, the prevalence and magnitude of coronary artery calcification
(i.e. Agatston score) and atherosclerotic plaque characteristics (density,
phenotype (calcified/partially calcified/non-calcified), degree of stenosis,
CT-derived fractional flow reserve), will be assessed in a subgroup of n=100
individuals with high versus n=50 with low post-exercise hs-cTnI
concentrations. Finally, we will assess the incidence of major adverse
cardiovascular events yearly and (cardiovascular and all-cause) mortality at
5-, 10-, 15-, and 20-years of follow-up.
Background summary
Cardiac troponins (cTn) have a key role in the diagnosis of a myocardial
injury[1, 2].
Intriguingly, exercise produces transient elevations of cTn concentrations[3],
mimicking the cTn kinetics of a myocardial infarction[4]. The clinical
relevance of exercise-induced elevations remains unclear. We recently showed
that the magnitude of post-exercise cTn concentrations is associated with an
increased risk for mortality and major adverse cardiovascular events in
long-distance walkers[5]. Furthermore, exercise-induced cTn responses were
different in recreational cyclists with occult obstructive coronary artery
disease compared to healthy controls[6, 7]. Hence, post-exercise elevations of
cTn concentrations could represent: 1) an acute coronary event, 2)
(sub)clinical myocardial injury, or 3) a physiological response. The
interpretation of cTn concentrations following exercise is, therefore,
challenging and causes clinical confusion[8]. Therefore, more insight into
physiological versus pathological post-exercise cTn concentrations is needed.
Study objective
Primary aim: To establish reference values for exercise-induced elevations of
cTn concentrations following walking, cycling and running exercise.
Secondary aim: Assess the prevalence of (sub)clinical coronary artery disease
in individuals with high versus low post-exercise cTn concentrations.
Tertiary aim: To determine the association between post-exercise cTn
concentrations and major adverse cardiovascular events and mortality during
long-term follow-up.
Study design
Observational cohort study.
Study burden and risks
Overall, the risks of this study are low, and all efforts will be made to
further minimize these risks. Visits 1 to 3 include a venous blood draw at
baseline (V1), within 6 hours post-exercise (V2) and after 24 - 48 hours
post-exercise (V3). All blood draws (3x30mL) are performed by an experienced
researcher/nurse/physician, but a hematoma may occur in ± 5% of the
participants. This will typically disappear within 2 weeks and is not
associated with any (functional) limitations. Participants may experience
transient pallor, dizziness, weakness or sweating following the blood draw of
30 ml per time point (90 ml in total). These symptoms generally disappear
rapidly.
A subgroup of 150 athletes will be invited for visit 4 to determine the
presence of (sub)clinical coronary artery disease using a contrast enhanced
coronary CT angiography. The occurrence of contrast nephropathy is extremely
rare in athletes with an estimated GFR >30 ml/min[9]. Mean radiation dose is
estimated at 4.5 mSv , while a recent study observed no evidence of DNA damage
in patients undergoing CT angiography with <7.5 mSv of radiation dose[10].
Incidental findings in the scan field may lead to additional diagnostic tests
with extra costs and risks not covered by this study. Incidental findings (i.e.
pulmonary nodules, pulmonary embolism and liver abnormalities) will be reported
to the general practitioner of the participant. For subjects with heart rates
>60 bpm, metoprolol will be administered iv. to lower heart rate and all
subjects will receive 2 puffs of nitro-glycerine (0,8mg) sublingually directly
before scanning to dilate the coronary arteries in concordance with clinical
routine protocol. This may temporarily lower blood pressure.
Philips van Leydenlaan 15
Nijmegen 6525EX
NL
Philips van Leydenlaan 15
Nijmegen 6525EX
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
• Participant of a mass-participation exercise event with a:
o Walking distance >=30 km
o Cycling distance >=120 km
o Running distance >=15 km
• Age: >= 40 and <70 years old
• Able to understand and perform study related procedures
For Phase 2 of the study (i.e. assessment of (sub)clinical coronary artery
disease), the following additional criteria are present:
• Free from (known) cardiovascular diseases
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded
from participation in phase 2 of this study (CT scans):
• Renal transplantation in the past
• Contrast nephropathy in the past
• eGFR < 30 ml/min
• Atrial fibrillation (heart rhythm disorder)
• Previous allergic reaction to iodine contrast
• Participation in other studies involving radiation
• Not willing to be informed about potential incidental findings from the
CT-scan
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL79864.091.22 |