Endothelial Function and Heart Rate Variability After Stenting (FUNKIS)

This study has been completed.
Sponsor:
Information provided by:
Helse Stavanger HF
ClinicalTrials.gov Identifier:
NCT00999323
First received: October 20, 2009
Last updated: NA
Last verified: October 2009
History: No changes posted

October 20, 2009
October 20, 2009
July 2007
March 2009   (final data collection date for primary outcome measure)
clinical restenosis, major cardiovascular event [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
endothelial function, heart rate variability [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Endothelial Function and Heart Rate Variability After Stenting
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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

serum, plasma and full blood

Probability Sample

patients who have been revascularized by coronary intervention with stent implantation

Restenosis or Adverse Cardiovascular Event
Device: stent implantation in coronary artery
Percuatenous Coronary Intervention with implanatation of a stent
coronary artery disease
patients who have been revascularized by PCI with stent implantation due to an acute coronary syndrome
Intervention: Device: stent implantation in coronary artery
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
October 2009
March 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT00999323
2007.061.07
No
Peter Scott Munk, MD, Stavanger University Hospital
Helse Stavanger HF
Not Provided
Not Provided
Helse Stavanger HF
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP