Endothelial Function and Heart Rate Variability After Stenting

Restenosis or Adverse Cardiovascular Event Clinical Trial

— FUNKIS  

Official title:

Endothelial Function and Heart Rate Variability After Stenting in Coronary Arteries

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00999323
• Other study ID #: 2007.061.07
• Status: Completed
• Phase: N/A
• First received: October 20, 2009
• Last updated: July 27, 2015
• Start date: July 2007
• Est. completion date: October 2009

Study information

• Verified date: October 2009
• Source: Helse Stavanger HF
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Ethics Committee
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Restenosis or Adverse Cardiovascular Event

Intervention

Device:
• stent implantation in coronary artery
Percuatenous Coronary Intervention with implanatation of a stent

Locations

Country	Name	City	State
Norway	Stavanger University Hospital	Stavanger

Sponsors (1)

Lead Sponsor	Collaborator
Helse Stavanger HF

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinical restenosis, major cardiovascular event		12 months	No
Secondary	endothelial function, heart rate variability		12 months	No