To assess cardiovascular structure and function, physical capacity and traditional CVD risk factors in i) physical active subject with MI and ii) physical active subjects without MI.
ID
Source
Brief title
Condition
- Myocardial disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Vascular structure and function (conduit artery endothelial function, conduit
artery diameter, blood flow, IMT, conduit and resistance artery structure, peak
hypereamic blood flow, exercise-induced vasodilation)
Plaque vulnerability by ultrasoiund and serum biomarkers (hs-CRP, SAA, IL-6,
MMP-9, MMP-2, TIMP-1, TIMP-2)
Cardiac structure and function (cardiac mass and dimensions, systolic and
diastolic function parameters, left and right ventricle strain rate)
Secondary outcome
Secondary objectives include groups comparisons of physical fitness and
traditional risk factors, i.e. cholesterol, lipid profile, HbA1C, insulin
sensitivity, blood pressure, and waist circumference.
Two extra blood samples will be drawn and stored for future analyses (if no
objection participant), in case relevant CVD genetic candidates become
available.
Background summary
The World Health Organization has reported that that since 1990, more people
have died worldwide from cardiovascular disease (CVD) than any other cause.
Previous studies support a strong inverse relationship between the amount of
physical activity CVD morbidity and mortality.
While physical inactivity is considered an important independent risk factor
for the development of CVD and atherosclerosis and increased physical activity
(i.e. exercise) is beneficial in the prevention and treatment of CVD, the
mechanisms that underlie the beneficial effects of physical activity are still
largely unknown. It appears that only ~60% of the beneficial effects of
exercise could be attributed to favourable changes in traditional risk factors
such as lipids, cholesterol, high blood pressure, etc. Plausible proposed
mechanisms for exercise-induced coronary heart disease protection include
improved endothelial function, attenuated plaque progression, stabilization of
vulnerable plaques, infarct sparing due to myocardial preconditioning,
correction of autonomic imbalance, reduction in myocardial oxygen demand,
decreased thrombosis, enhanced collateralization, and decreased inflammatory
mediator release. Although physical exercise seems to be a powerful preventive
tool for CVD, it is known that CVD and myocardial infarction (MI) occur in
physically active populations. Interestingly, post-mortem studies from the
1960s do not reveal any association between coronary atherosclerosis and
different levels of physical activity.
To further enhance the knowledge on potential underlying mechanism of CVD and
the role of physical activity level, the main objective of this proposal is to
compare cardiovascular structure and function in habitual physical active
subjects with or without MI.
Study objective
To assess cardiovascular structure and function, physical capacity and
traditional CVD risk factors in i) physical active subject with MI and ii)
physical active subjects without MI.
Study design
Exploratory Observational study
Study burden and risks
Noninvasive vascular and cardiac testing procedures in this study are not
related to any potential risk for the participant. Headache and dizziness of
short duration may occur following nitroglycerin spray. Although inflation of
the blood pressure cuff during the vascular measurements may induce a slight
uncomfortable sensation, this is brief (5 minutes) and stops when the cuff is
deflated. A possible complication of venipuncture is a hematoma, which is
induced in ~5% of all cases. To prevent complications, the blood withdrawal
will be performed by an experienced professional and sufficient pressure will
be provided after withdrawal of the needle.
At the department of Physiology, we have a long-standing tradition in
performing the non-invasive testing as used in this present study, i.e.
exercise test, cardiac and vascular function and structure measurements. All
procedures are performed routinely at the Department of Physiology and have
been accepted by the ethics committee in numerous previous applications in
healthy as well as various patients groups. Maximal cycling tests will be
performed at the hospital under supervision of highly qualified personnel.
Participants may experience benefits upon participation, as they will obtain
extensive information on their cardiovascular health and physical fitness
status.
Findings of this study will contribute to further enhance our understanding on
potential underlying mechanism of CVD and the role of physical activity.
Geert Grooteplein 21
6500 HB Nijmegen
NL
Geert Grooteplein 21
6500 HB Nijmegen
NL
Listed location countries
Age
Inclusion criteria
Informed consent
Men and women aged 40-70 years
For active groups, regular physical active (i.e. aerobic exercise such as running >=3 times a week), for at least 20 years
For MI groups, myocardial infarction within the past 5 years
Exclusion criteria
Smokers
Type I or II diabetes mellitus
Other diseases that interfere with exercise testing
For subject in non-MI groups:
- hypercholesterolemia
- hypertension
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 | NL38815.091.11 |