Ankle - Brachial Index Measurement in Atrial Fibrillation (AFABI)

Ankle - Brachial Index Measurement in Patients With Atrial Fibrillation Before and After Electrical Cardioversion

Consecutive patients with atrial fibrillation will be admitted to the hospital for electrical cardioversion. Ankle brachial index will be measured three times with oscillometric method and three times with doppler method. Two study sessions will be performed: the first before and the second after electrical cardioversion. The first session will be ended before anesthesia. The second session will be started before a conscious patient will be transported from intensive care unit to general ward.

All the measurements will be taken in the intensive care unit at an ambient temperature of 21° C, after patients will give their written informed consent to participate in the study. All patients will be awake, fasting and in the supine position. ABI will be measured according to the guidelines issued by AHA. Systolic blood pressure will be measured using a Doppler device (Echo Sounder ES-101EX, Hadeco, Japan) and a validated and calibrated aneroid sphygmomanometer (Minimus II, Rister, Germany). Measurement of ABI using oscillometric method will be performed using WatchBP Office ABI system (Microlife WatchBP AG, Widnau, Switzerland). The appropriate cuff size will be used with the width of the cuff being at least 40% of the limb circumference. The arm with higher systolic blood pressure will be used to calculate the ABI. Higher systolic blood pressure measured on the posterior tibial or dorsalis pedis artery will be used to calculate the ABI. During both study sessions ABI measurements will be repeated 3 times with each method in the reverse order of the preceding measurement e.g., in the case of the initial counterclockwise sequence: right arm, right popliteal, right dorsalis pedis, left popliteal, left dorsalis pedis, left arm, right arm, the clockwise sequence will be used, starting and ending with the left arm. The same sequence of limb pressure measurements will be used used during the study.

A sample size calculation was based on the preliminary observations made by the study team. It was calculated that the study sample size of 79 subjects would be needed to detect a difference of 0.1 in the ABI measured in sinus rhythm and during atrial fibrillation, with a two-tailed α of 0.05 and a (1-β) of 0.90. The investigators initial estimate of sample size of 115 patients incorporated an assumption of dropout due to non-effective electrical cardioversion, patient decision to quit study or failure to obtain adequate ABI.

The measurements will be repeated three times with each method and for the each method the mean will be used for the calculations. Investigator - study nurse, trained at the vascular department, will perform all ABI measurements.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation Fluttering
• Intervention / Treatment: Device: ABI measurement using both doppler and oscillometric method

• Study Type: Interventional
• Enrollment (Actual): 115
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients undergoing electrical cardioversion due to atrial fibrillation

Exclusion Criteria:

• Circulatory instability
• Use of vasoconstrictive agents
• Limb trauma
• Upper limb artery stenosis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Single arm; Interventions - repeated ankle - brachial index measurement before and after electrical cardioversion in patients with atrial fibrillation	Device: ABI measurement using both doppler and oscillometric method; Other Names: doppler method (Echo Sounder ES-101EX, Hadeco, Japan and Minimus II, Rister, Germany); oscillometric method (Microlife WatchBP AG, Widnau, Switzerland)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference Between ABI (Ankle - Brachial Index) Before Electrical Cardioversion Using Two Methods (Doppler and Oscillometric).	3 ABI measurements using both methods (doppler and oscillometric) were performed per participant and the Mean value was considered for each participant, and then a Median value was calculated across participants.	Through the study

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference Between ABI Measured Before and After Electrical Cardioversion Using Doppler Method.	3 ABI measurements using doppler method were performed per participant and the Mean value was considered for each participant, and then a Median value was calculated across participants	Through the study period

Collaborators and Investigators

• Sponsor: Medical University of Warsaw
• Investigators: Principal Investigator: Maciej Sinski, M.D., Ph.D., Medical University of Warsaw

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: December 2, 2016
• First Submitted That Met QC Criteria: December 5, 2016
• First Posted (Estimate): December 8, 2016

Study Record Updates

• Last Update Posted (Actual): July 18, 2017
• Last Update Submitted That Met QC Criteria: June 19, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: ankle - brachial index
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: AFABI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Raw data will be attached to manuscript.