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
About this trial
This is an interventional diagnostic trial for Atrial Fibrillation Fluttering focused on measuring ankle - brachial index
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
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
NCT ID
NCT02986282
First Posted
December 2, 2016
Last Updated
June 19, 2017
Sponsor
Medical University of Warsaw
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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