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Validation Study of Pulse Wave Velocity and Augmentation Index in Atrial Fibrillation

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
SphygmoCor version 7, AtCor Medical, Sydney, Australia
Sponsored by
Onze Lieve Vrouw Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Atrial Fibrillation focused on measuring pulse wave velocity, augmentation index, central pulse pressure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • man or woman, age ≥18 years
  • signed written informed consent
  • atrial fibrillation or flutter
  • scheduled for elective electrical cardioversion

Exclusion Criteria:

  • 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

Sites / Locations

  • OLV Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Validation

Arm Description

SphygmoCor version 7, AtCor Medical, Sydney, Australia

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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)
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
Heart rate (beats/min) before and after cardioversion and their potential effects on changes in PWV and AI after cardioversion.

Full Information

First Posted
March 28, 2016
Last Updated
September 6, 2016
Sponsor
Onze Lieve Vrouw Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02754349
Brief Title
Validation Study of Pulse Wave Velocity and Augmentation Index in Atrial Fibrillation
Official Title
Assessment of Pulse Wave Velocity and Augmentation Index in Patients With Atrial Fibrillation Before and After Electrical Cardioversion: a Validation Study.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
February 2015 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Onze Lieve Vrouw Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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). 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
pulse wave velocity, augmentation index, central pulse pressure

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Validation
Arm Type
Experimental
Arm Description
SphygmoCor version 7, AtCor Medical, Sydney, Australia
Intervention Type
Device
Intervention Name(s)
SphygmoCor version 7, AtCor Medical, Sydney, Australia
Intervention Description
Pulse wave velocity, augmentation index and central blood pressure measurement with applanation tonometry before and after electrical cardioversion
Primary Outcome Measure Information:
Title
Pulse Wave Velocity (in meters per second) before and after cardioversion
Description
with assessment of agreement on the individual level and systematic bias using the group average before and after cardioversion
Time Frame
immediate
Secondary Outcome Measure Information:
Title
Augmentation Index (in percent) before and after cardioversion
Description
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)
Time Frame
immediate
Title
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
Title
Heart rate (beats/min) before and after cardioversion and their potential effects on changes in PWV and AI after cardioversion.
Time Frame
immediate

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: man or woman, age ≥18 years signed written informed consent atrial fibrillation or flutter scheduled for elective electrical cardioversion Exclusion Criteria: 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
Facility Information:
Facility Name
OLV Hospital
City
Aalst
ZIP/Postal Code
9300
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No

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Validation Study of Pulse Wave Velocity and Augmentation Index in Atrial Fibrillation

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