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
  Purpose

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.


Condition Intervention
Restenosis or Adverse Cardiovascular Event
Device: stent implantation in coronary artery

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Endothelial Function and Heart Rate Variability After Stenting in Coronary Arteries

Further study details as provided by Helse Stavanger HF:

Primary Outcome Measures:
  • clinical restenosis, major cardiovascular event [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • endothelial function, heart rate variability [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

serum, plasma and full blood


Enrollment: 100
Study Start Date: July 2007
Study Completion Date: October 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
coronary artery disease
patients who have been revascularized by PCI with stent implantation due to an acute coronary syndrome
Device: stent implantation in coronary artery
Percuatenous Coronary Intervention with implanatation of a stent

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

patients who have been revascularized by coronary intervention with stent implantation

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00999323

Locations
Norway
Stavanger University Hospital
Stavanger, Norway, 4068
Sponsors and Collaborators
Helse Stavanger HF
  More Information

No publications provided

Responsible Party: Peter Scott Munk, MD, Stavanger University Hospital
ClinicalTrials.gov Identifier: NCT00999323     History of Changes
Other Study ID Numbers: 2007.061.07
Study First Received: October 20, 2009
Last Updated: October 20, 2009
Health Authority: Norway: Ethics Committee

ClinicalTrials.gov processed this record on October 23, 2014