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Completed

NCT Number: NCT00999323

Endothelial Function and Heart Rate Variability After Stenting

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Stavanger University Hospital

Stavanger, 4068, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients after successful revascularization by percutaneous coronary intervention with stent implantation for single coronary artery disease

Exclusion criteria

  • Multivessel coronary artery disease
  • Left ventricular dysfunction defined as ejection fraction (EF) < 50%
  • Former aortocoronary bypass-surgery
  • Systemic inflammatory diseases other than atherosclerosis
  • inability to give informed consent
  • Renal failure (kreatinin > 250 mmol/l)
  • Refusion to participate

Treatment and study plan

stent implantation in coronary artery

Device

Percuatenous Coronary Intervention with implanatation of a stent

Primary outcomes

  1. clinical restenosis, major cardiovascular event

    Time frame: 12 months

Secondary outcomes

  1. endothelial function, heart rate variability

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Helse Stavanger HF

Other Gov

Registry information

Official study title

Endothelial Function and Heart Rate Variability After Stenting in Coronary Arteries

Acronym: FUNKIS

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Oct 21, 2009
Registry last updated
Jul 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.