Primary objective: - To assess the prevalence and severity of coronary artery disease in asymptomatic older (> 45 years) men who undergo exercise testing as part of a sports medical evaluation, with minimally invasive cardiac multidetector…
ID
Source
Brief title
Condition
- Coronary artery disorders
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Risk of CV events determined with SCORE.
- MDCT-cardiac imaging data: calcium score (Agatston, volume, mass), presence
and severity of coronary artery disease, Total coronary atherosclerotic burden.
Secondary outcome
- Life time physical activity
- Incidental findings on MDCT scanning
- Safety (in particular radiation exposure) and tolerability of MDCT scanning.
Background summary
Although regular physical activity is the cornerstone of every effort to
prevent cardiovascular events, (vigorous) exercise is associated with a
transiently increased risk of acute cardiac events, particularly in untrained
persons. More than 90% of acute exercise related cardiac events occur in men,
predominantly those aged 45 years or over. Acute events in young athletes (aged
35 years or younger) are mainly caused by inherited cardiac diseases, whereas
events in older athletes are largely caused by coronary artery disease. Despite
the rare occurrence of cardiac events in young athletes (approx. 1 per 100.000
athletes per year) the study group of sport cardiology of the European Society
of Cardiology (ESC) recommends mandatory pre-participation screening of
athletes aged 35 years or younger. Intuitively, it would make more sense to
direct screening efforts at older athletes as they have a higher risk of acute
cardiac events. Effectively this would imply screening for the presence of
coronary artery disease in (largely) asymptomatic athletes to identify those at
a high risk of cardiovascular events. Minimally invasive cardiac imaging is
likely to play an important role in this group.
Study objective
Primary objective:
- To assess the prevalence and severity of coronary artery disease in
asymptomatic older (> 45 years) men who undergo exercise testing as part of a
sports medical evaluation, with minimally invasive cardiac multidetector
computed tomography (MDCT) imaging (determining the Agatston score, total
coronary atherosclerotic burden and the presence of coronary artery disease -
defined as luminal narrowing of at least 50%), irrespective of future
cardiovascular disease (CVD) risk as estimated with SCORE and the results of
the exercise test.
Secondary objectives:
- To determine the relation between conventional CV risk factors and coronary
artery disease (CAD) in this group.
- To determine the relation between lifetime physical activity and CAD in this
group.
Study design
The MARC study will be a cross-sectional diagnostic study of 300 asymptomatic
men aged 45 years or older undergoing exercise testing as part of a sports
medical work-up at Meander Medical Center, Amersfoort, who will be invited to
undergo minimally invasive cardiac MDCT imaging. The cardiac MDCT results,
combined with the conventional CV risk profile, will be used to provide the
participants with a tailored cardiovascular advice, based on the prevailing
Dutch guidelines and participants will be followed up for an additional five
years to determine the occurance of hard cardiovascular end-points.
Study burden and risks
For a detailed review of the potential risks, i.e. risks associated with
cardiac MDCT, refer to page 12 of the protocol. In brief:
• Adverse reaction to the contrast medium (nausea, skin hives in 1 to 3% of
participants, fatal adverse reactions in 0.001%)
• Contrast medium-induced renal insufficiency
• Cancer due to exposure to ionizing radiation (estimated to equal 1 year of
background radiation)
• Accidental findings in the scan field may lead to additional diagnostic tests
with extra costs and risks not covered by this study.
• Administration of sublingual nitroglycerin prior to CT scanning may cause
transient sensations of headache and flushing.
• Administration of metoprolol to lower heart rate prior to CT scanning may
cause transient sensations of headache and dizziness. It is expected that only
a minority of participants will receive metoprolol to lower heart rate below 70
beats/minute.
Utrechtseweg 160
3800 BM Amersfoort
NL
Utrechtseweg 160
3800 BM Amersfoort
NL
Listed location countries
Age
Inclusion criteria
Male athletes aged 45 years or older age, asymptomatic for heart disease who undergo exercise testing as part of a sports medical evaluation, who are able to understand the study procedure and objectives
Exclusion criteria
Known cardiovascular disease
Rhythm other than sinusrhythm
Pacemaker rhythm
Not able to hold breath for 25 sec.
Asthma/COPD and resting heart rate > 70/min after intravenous administration with beta blocker)
Iodine-allergy
Hypertension (Blood pressure > 200/110 mmHg)
Obesity BMI >40 kg/m2
Decreased renal function (GFR <60 mL/min)
Language barrier
Unwillingness to be informed about possible incedental findings at 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 | NL38234.100.11 |