Restenosis or Adverse Cardiovascular EventFUNKISNCT00999323
Endothelial Function and Heart Rate Variability After Stenting
An observational study of Restenosis or Adverse Cardiovascular Event, run by Helse Stavanger HF at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Restenosis or Adverse Cardiovascular Event
- What is being tested?
- stent implantation in coronary artery
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteNorway
- Study dates
- Jul 2007to Oct 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients who have been revascularized by coronary intervention with stent implantation
Who may be able to join
- Patients after successful revascularization by percutaneous coronary intervention with stent implantation for single coronary artery disease
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- stent implantation in coronary artery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stent implantation in coronary arteryDevice
Percuatenous Coronary Intervention with implanatation of a stent
| Study group | Role | What they receive |
|---|---|---|
| coronary artery disease | patients who have been revascularized by PCI with stent implantation due to an acute coronary syndrome Receives: Device: stent implantation in coronary artery |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical restenosis, major cardiovascular event
Measured: 12 months
Secondary outcomes (1)
endothelial function, heart rate variability
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2009 (estimated)
- Study startJul 2007
- Primary completionMar 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Restenosis or Adverse Cardiovascular EventStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helse Stavanger HF
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00999323
- Sponsor's protocol ID
- 2007.061.07
- Acronym
- FUNKIS
- Status last verified
- Oct 2009
- First submitted
- 20 Oct 2009
- Last updated
- 28 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endothelial Function and Heart Rate Variability After Stenting in Coronary Arteries
- ClinicalTrials.gov ID
- NCT00999323
- Acronym / sponsor ID
- FUNKIS / 2007.061.07
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Helse Stavanger HFOther government
- Study start
- Jul 2007
- Primary completion
- Mar 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 21 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| coronary artery disease | – | Device: stent implantation in coronary arterypatients who have been revascularized by PCI with stent implantation due to an acute coronary syndrome |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients who have been revascularized by coronary intervention with stent implantation
Key inclusion criteria (1 listed)
- Patients after successful revascularization by percutaneous coronary intervention with stent implantation for single coronary artery disease
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| stent implantation in coronary arteryPercuatenous Coronary Intervention with implanatation of a stent | Device | coronary artery disease |
Primary outcome
clinical restenosis, major cardiovascular event
Time frame: 12 months
1 secondary outcome
endothelial function, heart rate variability
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2015.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Restenosis or Adverse Cardiovascular Event, run by Helse Stavanger HF at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical restenosis, major cardiovascular event (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2015.