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Ankle - Brachial Index Measurement in Atrial Fibrillation (AFABI)

Primary Purpose

Atrial Fibrillation Fluttering

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ABI measurement using both doppler and oscillometric method
Sponsored by
Medical University of Warsaw
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Atrial Fibrillation Fluttering focused on measuring ankle - brachial index

Eligibility Criteria

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

Inclusion Criteria:

  • Patients undergoing electrical cardioversion due to atrial fibrillation

Exclusion Criteria:

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Single arm

    Arm Description

    Interventions - repeated ankle - brachial index measurement before and after electrical cardioversion in patients with atrial fibrillation

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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

    Full Information

    First Posted
    December 2, 2016
    Last Updated
    June 19, 2017
    Sponsor
    Medical University of Warsaw
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02986282
    Brief Title
    Ankle - Brachial Index Measurement in Atrial Fibrillation
    Acronym
    AFABI
    Official Title
    Ankle - Brachial Index Measurement in Patients With Atrial Fibrillation Before and After Electrical Cardioversion
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2012 (undefined)
    Primary Completion Date
    December 2015 (Actual)
    Study Completion Date
    December 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Medical University of Warsaw

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Atrial Fibrillation Fluttering
    Keywords
    ankle - brachial index

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Single arm
    Arm Type
    Other
    Arm Description
    Interventions - repeated ankle - brachial index measurement before and after electrical cardioversion in patients with atrial fibrillation
    Intervention Type
    Device
    Intervention Name(s)
    ABI measurement using both doppler and oscillometric method
    Other Intervention Name(s)
    doppler method (Echo Sounder ES-101EX, Hadeco, Japan and Minimus II, Rister, Germany), oscillometric method (Microlife WatchBP AG, Widnau, Switzerland)
    Primary Outcome Measure Information:
    Title
    Difference Between ABI (Ankle - Brachial Index) Before Electrical Cardioversion Using Two Methods (Doppler and Oscillometric).
    Description
    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
    Secondary Outcome Measure Information:
    Title
    Difference Between ABI Measured Before and After Electrical Cardioversion Using Doppler Method.
    Description
    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

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients undergoing electrical cardioversion due to atrial fibrillation Exclusion Criteria: Circulatory instability Use of vasoconstrictive agents Limb trauma Upper limb artery stenosis
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Maciej Sinski, M.D., Ph.D.
    Organizational Affiliation
    Medical University of Warsaw
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    Raw data will be attached to manuscript.

    Learn more about this trial

    Ankle - Brachial Index Measurement in Atrial Fibrillation

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