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

Tracking Information
First Received Date ^ICMJE	October 20, 2009
Last Updated Date	October 20, 2009
Start Date ^ICMJE	July 2007
Primary Completion Date	March 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: October 20, 2009)	clinical restenosis, major cardiovascular event [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE (submitted: October 20, 2009)	endothelial function, heart rate variability [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Endothelial Function and Heart Rate Variability After Stenting
Official Title ^ICMJE	Endothelial Function and Heart Rate Variability After Stenting in Coronary Arteries
Brief 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.
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.
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Cohort Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Retention: Samples With DNA Description: serum, plasma and full blood
Sampling Method	Probability Sample
Study Population	patients who have been revascularized by coronary intervention with stent implantation
Condition ^ICMJE	Restenosis or Adverse Cardiovascular Event
Intervention ^ICMJE	Device: stent implantation in coronary artery Percuatenous Coronary Intervention with implanatation of a stent
Study Group/Cohort (s)	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
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	100
Completion Date	October 2009
Primary Completion Date	March 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Norway

Administrative Information
NCT Number ^ICMJE	NCT00999323
Other Study ID Numbers ^ICMJE	2007.061.07
Has Data Monitoring Committee	No
Responsible Party	Peter Scott Munk, MD, Stavanger University Hospital
Study Sponsor ^ICMJE	Helse Stavanger HF
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Helse Stavanger HF
Verification Date	October 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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