Atrial FibrillationNCT02754349
Validation Study of Pulse Wave Velocity and Augmentation Index in Atrial Fibrillation
A study testing SphygmoCor version 7, AtCor Medical, Sydney, Australia in people with Atrial Fibrillation, run by Onze Lieve Vrouw Hospital at 1 site in Belgium.
Trial summary
This study aims to evaluate the reliability of measurements of arterial stiffness (pulse wave velocity (PWV), pulse wave contour analysis (PWA), central augmentation index (AIx) and pulse pressure (PP)) in atrial fibrillation (AF). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- SphygmoCor version 7, AtCor Medical, Sydney, Australia
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBelgium
- Study dates
- Feb 2015to May 2016
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- man or woman, age ≥18 years
- signed written informed consent
- atrial fibrillation or flutter
- scheduled for elective electrical cardioversion
Who cannot join
- inability to understand the nature, scope and possible consequences of the study
- clinical conditions that could hamper hemodynamic measurements (absence of femoral pulse, systolic blood pressure < 90 mmHg)
- presence of prosthetic material (grafts, stents or stent-grafts) in the aorta or femoral arteries
- any condition precluding the execution of the cardioversion procedure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Pulse Wave Velocity and Augmentation Index in Patients With Atrial Fibrillation Before and After Electrical Cardioversion: a Validation Study.
This study aims to evaluate the reliability of measurements of arterial stiffness (pulse wave velocity (PWV), pulse wave contour analysis (PWA), central augmentation index (AIx) and pulse pressure (PP)) in atrial fibrillation (AF). For this purpose 30 AF patients scheduled for electrical cardioversion will be included. PWV and PWA measurements will be carried out before and after cardioversion.
Read the detailed description
In recent years the role of arterial stiffness in the development of cardiovascular diseases has garnered attention. Indeed, arterial stiffness is now well accepted as one of the most important determinants of increasing systolic and pulse pressure thus playing a germane role in the risk of stroke and myocardial infarction. Longitudinal epidemiological studies have demonstrated the independent predictive value of arterial stiffness for cardiovascular events after adjustment for classical cardiovascular risk factors. Arterial stiffness is now a recognized intermediate endpoint for cardiovascular events. The pressure wave speed in large arteries is directly related to square root of the elastic modulus of the arterial wall (Moens-Korteweg Equation). Carotid-femoral PWV is considered the gold standard method for assessing aortic stiffness. The stiffness gradient along the aorta and central arteries, local arterial branchings and narrowing of the arterial lumen cause partial reflections of forward pressure waves traveling back to the central aorta. Forward and reflected pressure waves overlap, and the final amplitude and shape of the pulse pressure wave are determined by the phase timing of these component waves. In the aorta, forward and reflected waves are not in phase. In subjects with low PWV, reflected waves reach the central arteries during late-systole and diastole, increasing the aortic pressure in early diastole, which is physiologically advantageous. With increasing PWV, the reflected waves return earlier and impact on the central arteries during systole, thereby augmenting systolic and left ventricular pressure. This is why increasing PWV is accompanied by increasing AIx (defined as the difference between the second and first systolic pressure peak) and central PP. AIx and central PP depend on the speed of wave travel, the amplitude of reflected wave and the duration and pattern of ventricular ejection, especially with respect to change in heart rate and ventricular contractility. Where PWV is considered a direct measure of arterial stiffness, central PP and AIx are only indirect, surrogate measures. However, they provide additional information concerning wave reflections. Whether PWV, AIx and central PP measurements are influenced by the presence of AF is unknown. Studying AF patients before and after elective electrical cardioversion offers an appropriate setting to evaluate the effect of heart rate and rhytm on PWV, AIx and central PP. Patient specific confounding factors are minimized because each patient serves as its own control.
- Conditions
- Atrial Fibrillation
- Being tested
- SphygmoCor version 7, AtCor Medical, Sydney, Australia
- Keywords
- pulse wave velocity, augmentation index, central pulse pressure
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SphygmoCor version 7, AtCor Medical, Sydney, AustraliaDevice
Pulse wave velocity, augmentation index and central blood pressure measurement with applanation tonometry before and after electrical cardioversion
| Study group | Role | What they receive |
|---|---|---|
| Validation | Experimental | SphygmoCor version 7, AtCor Medical, Sydney, Australia Receives: Device: SphygmoCor version 7, AtCor Medical, Sydney, Australia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulse Wave Velocity (in meters per second) before and after cardioversion
with assessment of agreement on the individual level and systematic bias using the group average before and after cardioversion
Measured: immediate
Secondary outcomes (3)
Augmentation Index (in percent) before and after cardioversion
with assessment of agreement on the individual level and systematic bias using the group average before and after cardioversion.hemodynamic parameters obtained from pulse wave analysis (including AIx en central blood pressure)
Measured: immediate
Central systolic blood pressure, diastolic blood pressure, mean arterial pressure and pulse pressure (in mmHg) before and after cardioversion and their potential effects on changes in PWV and AI after cardioversion
Measured: immediate
Heart rate (beats/min) before and after cardioversion and their potential effects on changes in PWV and AI after cardioversion.
Measured: immediate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2016 (estimated)
- Study startFeb 2015
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Onze Lieve Vrouw Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rogier Caluwe, Onze Lieve Vrouw Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02754349
- Sponsor's protocol ID
- 2014/091
- Status last verified
- Apr 2016
- First submitted
- 28 Mar 2016
- Last updated
- 7 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Pulse Wave Velocity and Augmentation Index in Patients With Atrial Fibrillation Before and After Electrical Cardioversion: a Validation Study.
- ClinicalTrials.gov ID
- NCT02754349
- Acronym / sponsor ID
- 2014/091
- Conditions
- Atrial Fibrillation
- Keywords
- pulse wave velocity, augmentation index, central pulse pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Onze Lieve Vrouw HospitalUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 28 Apr 2016 (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.
This study aims to evaluate the reliability of measurements of arterial stiffness (pulse wave velocity (PWV), pulse wave contour analysis (PWA), central augmentation index (AIx) and pulse pressure (PP)) in atrial fibrillation (AF). For this purpose 30 AF patients scheduled for electrical cardioversion will be included. PWV and PWA measurements will be carried out before and after cardioversion.
Detailed description
In recent years the role of arterial stiffness in the development of cardiovascular diseases has garnered attention. Indeed, arterial stiffness is now well accepted as one of the most important determinants of increasing systolic and pulse pressure thus playing a germane role in the risk of stroke and myocardial infarction. Longitudinal epidemiological studies have demonstrated the independent predictive value of arterial stiffness for cardiovascular events after adjustment for classical cardiovascular risk factors. Arterial stiffness is now a recognized intermediate endpoint for cardiovascular events. The pressure wave speed in large arteries is directly related to square root of the elastic modulus of the arterial wall (Moens-Korteweg Equation). Carotid-femoral PWV is considered the gold standard method for assessing aortic stiffness. The stiffness gradient along the aorta and central arteries, local arterial branchings and narrowing of the arterial lumen cause partial reflections of forward pressure waves traveling back to the central aorta. Forward and reflected pressure waves overlap, and the final amplitude and shape of the pulse pressure wave are determined by the phase timing of these component waves. In the aorta, forward and reflected waves are not in phase. In subjects with low PWV, reflected waves reach the central arteries during late-systole and diastole, increasing the aortic pressure in early diastole, which is physiologically advantageous. With increasing PWV, the reflected waves return earlier and impact on the central arteries during systole, thereby augmenting systolic and left ventricular pressure. This is why increasing PWV is accompanied by increasing AIx (defined as the difference between the second and first systolic pressure peak) and central PP. AIx and central PP depend on the speed of wave travel, the amplitude of reflected wave and the duration and pattern of ventricular ejection, especially with respect to change in heart rate and ventricular contractility. Where PWV is considered a direct measure of arterial stiffness, central PP and AIx are only indirect, surrogate measures. However, they provide additional information concerning wave reflections. Whether PWV, AIx and central PP measurements are influenced by the presence of AF is unknown. Studying AF patients before and after elective electrical cardioversion offers an appropriate setting to evaluate the effect of heart rate and rhytm on PWV, AIx and central PP. Patient specific confounding factors are minimized because each patient serves as its own control.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Validation | Experimental | Device: SphygmoCor version 7, AtCor Medical, Sydney, AustraliaSphygmoCor version 7, AtCor Medical, Sydney, Australia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- man or woman, age ≥18 years
- signed written informed consent
- atrial fibrillation or flutter
- scheduled for elective electrical cardioversion
Key exclusion criteria (4 listed)
- inability to understand the nature, scope and possible consequences of the study
- clinical conditions that could hamper hemodynamic measurements (absence of femoral pulse, systolic blood pressure < 90 mmHg)
- presence of prosthetic material (grafts, stents or stent-grafts) in the aorta or femoral arteries
- any condition precluding the execution of the cardioversion procedure
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 |
|---|---|---|
| SphygmoCor version 7, AtCor Medical, Sydney, AustraliaPulse wave velocity, augmentation index and central blood pressure measurement with applanation tonometry before and after electrical cardioversion | Device | Validation |
Primary outcome
Pulse Wave Velocity (in meters per second) before and after cardioversion
Time frame: immediate
with assessment of agreement on the individual level and systematic bias using the group average before and after cardioversion
3 secondary outcomes
Augmentation Index (in percent) before and after cardioversion
Time frame: immediate
Central systolic blood pressure, diastolic blood pressure, mean arterial pressure and pulse pressure (in mmHg) before and after cardioversion and their potential effects on changes in PWV and AI after cardioversion
Time frame: immediate
Heart rate (beats/min) before and after cardioversion and their potential effects on changes in PWV and AI after cardioversion.
Time frame: immediate
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 7 Sep 2016.
- Individual participant dataSharing planned: No
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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?
A study testing SphygmoCor version 7, AtCor Medical, Sydney, Australia in people with Atrial Fibrillation, run by Onze Lieve Vrouw Hospital at 1 site in Belgium.
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 4 inclusion and 4 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 7 Sep 2016. 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 Belgium. 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?
Pulse Wave Velocity (in meters per second) before and after cardioversion (time frame: immediate). 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 7 Sep 2016.