Restenosis or Adverse Cardiovascular Event Clinical Trial
Official title:
Endothelial Function and Heart Rate Variability After Stenting in Coronary Arteries
The objective of this study is to evaluate whether impaired endothelial function and low
heart rate variability are associated with clinical restenosis after percutaneous coronary
intervention with stent implantation in patients with angina or acute coronary syndrome.
Furthermore, the study examines a potential correlation between biomarkers of endothelial
cell activation and endothelial dysfunction.
Background Atherosclerosis is a chronic, systemic and diffusely distributed disease causing
focal complications in different vascular beds.
Impaired endothelial function is the initial step in the progressive course of
atherosclerosis . Endothelial dysfunction is considered a systemic process and both coronary
and peripheral endothelial dysfunction have been shown to be independently associated with
cardiovascular events .
Percutanenous coronary intervention (PCI) with implantation of stent is the treatment of
choice in symptomatic stenotic coronary artyery disease (CAD), but in-stent restenosis and
progression of disease remains its main limitation. Early identification of patients at risk
of restenosis after PCI would therefore be of clinical value. There is only limited
prospective data on the role of peripheral endothelial dysfunction after PCI predicting
restenosis and cardiovascular events , , .
Furthermore, it is unknown if peripheral endothelial dysfunction is associated with
increased levels of biomarkers of endothelial cell activation in this population.
There are conflicting data on inflammatory markers as high-sensitivity CRP with regard to
endothelial function.
Low heart rate variability (HRV) predicts automic dysfunction and is a strong and
independent predictor of mortality in patients with coronary artery disease (CAD) . Clinical
depression after myocardial infarction is associated with decreased HRV, linking depression
to increased cardiac mortality in post-myocardial infarction patients . Whether decreased
HRV is associated with endothelial dysfunction or restenosis is unknown.
Objective The objective of this study is to evaluate whether impaired endothelial function
and low HRV are associated with clinical restenosis.
Furthermore, the study examines a potential correlation between biomarkers of endothelial
cell activation and endothelial dysfunction.
Another issue is depression after PCI and a potential association with impaired endothelial
function and increased levels of makers for endothelial activation.
Methods
Subjects This prospective study includes consecutively patients with acute coronary
syndromes undergoing PCI with stent implantation for significant single vessel disease at
Stavanger University Hospital, Stavanger, Norway. Patients will be followed for at least 6
months.
Exclusion criteria are multivessel disease, left ventricular dysfunction defined as ejection
fraction (EF) < 50%, former aortocoronary bypass-surgery, systemic inflammatory diseases
other than atherosclerosis, cognitive impairement, severe psychiatric disorder, renal
failure (kreatinin > 250 mmol/l), refusion to participate.
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Observational Model: Cohort, Time Perspective: Prospective