Skip to content

Ankle - Brachial Index Measurement in Atrial Fibrillation

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02986282
Acronym
AFABI
Enrollment
115
Registered
2016-12-08
Start date
2012-10-31
Completion date
2015-12-31
Last updated
2017-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation Fluttering

Keywords

ankle - brachial index

Brief summary

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.

Interventions

DEVICEABI measurement using both doppler and oscillometric method

Sponsors

Medical University of Warsaw
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Patients undergoing electrical cardioversion due to atrial fibrillation

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Difference Between ABI (Ankle - Brachial Index) Before Electrical Cardioversion Using Two Methods (Doppler and Oscillometric).Through the study3 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.

Secondary

MeasureTime frameDescription
Difference Between ABI Measured Before and After Electrical Cardioversion Using Doppler Method.Through the study period3 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

Participant flow

Recruitment details

One hundred and fifteen consecutive patients with atrial fibrillation admitted to Department of Internal Medicine, Hypertension and Vascular Diseases, Medical University of Warsaw for electrical cardioversion were screened. Participants were recruited to the study from October 2012 up to December 2015.

Participants by arm

ArmCount
Single Arm
Interventions - repeated ankle - brachial index measurement before and after electrical cardioversion in patients with atrial fibrillation ABI measurement using both doppler and oscillometric method.
99
Total99

Baseline characteristics

CharacteristicSingle Arm
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
61 Participants
Age, Categorical
Between 18 and 65 years
38 Participants
Age, Continuous66.5 years
STANDARD_DEVIATION 11
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
0 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
99 Participants
Region of Enrollment
Poland
99 participants
Sex: Female, Male
Female
36 Participants
Sex: Female, Male
Male
63 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
0 / 99
serious
Total, serious adverse events
0 / 99

Outcome results

Primary

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.

Time frame: Through the study

ArmMeasureGroupValue (MEDIAN)
Single ArmDifference Between ABI (Ankle - Brachial Index) Before Electrical Cardioversion Using Two Methods (Doppler and Oscillometric).ABI oscillometric before1.21 ratio
Single ArmDifference Between ABI (Ankle - Brachial Index) Before Electrical Cardioversion Using Two Methods (Doppler and Oscillometric).ABI oscillometric after1.215 ratio
Single ArmDifference Between ABI (Ankle - Brachial Index) Before Electrical Cardioversion Using Two Methods (Doppler and Oscillometric).ABI doppler before1.14 ratio
Single ArmDifference Between ABI (Ankle - Brachial Index) Before Electrical Cardioversion Using Two Methods (Doppler and Oscillometric).ABI doppler after1.18 ratio
Comparison: 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. Our initial estimate of sample size of 115 patients incorporated an assumption of dropout. Intra-observer variability was calculated using intra-class correlation coefficient.p-value: <0.0595% CI: [-0.0799661, -0.0449876]Wilcoxon (Mann-Whitney)
Secondary

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

Time frame: Through the study period

ArmMeasureGroupValue (MEDIAN)
Single ArmDifference Between ABI Measured Before and After Electrical Cardioversion Using Doppler Method.ABI doppler before1.14 ratio
Single ArmDifference Between ABI Measured Before and After Electrical Cardioversion Using Doppler Method.ABI doppler after1.18 ratio
p-value: <0.0595% CI: [-0.039992, -0.0100226]Wilcoxon (Mann-Whitney)

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026