Back to resultsArterial Stiffness and Atrial Fibrillation
Primary Purpose
Atrial Fibrillation
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Carotid Ultrasound
Sponsored by
About this trial
This is an interventional prevention trial for Atrial Fibrillation
Eligibility Criteria
Inclusion Criteria:
- All patients with persistent AF, scheduled for electrical cardioversion
Exclusion Criteria:
- Unable to provide informed consent.
- Patients with intramural thrombus or other conditions that preclude the performance of electrical cardioversion.
- Patients with prior carotid stents.
Sites / Locations
- Mayo Clinic in Rochester
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Subjects with atrial fibrillation
Arm Description
Subjects with atrial fibrillation that have been clinically scheduled for an electrical cardioversion procedure will have carotid ultrasound testing done before and after the procedure
Outcomes
Primary Outcome Measures
Recurrence of Atrial Fibrillation following cardioversion
We will follow up by phone or look through medical records to record the number of subjects that have had a recurrence of Atrial Fibrillation. We are also looking if we can correlate the recurrence with arterial stiffness.
Secondary Outcome Measures
Occurrence of heart failure
Number of subjects to have heart failure following cardioversion
Occurrence of stroke
Number of subjects to have a stroke following cardioversion
Occurrence of hospitalization
Number of subjects that have been hospitalized following cardioversion
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04160663
Brief Title
Arterial Stiffness and Atrial Fibrillation
Official Title
Arterial Stiffness and Atrial Fibrillation
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Terminated
Why Stopped
Due to COVID and staffing issues study was terminated
Study Start Date
October 29, 2019 (Actual)
Primary Completion Date
October 5, 2020 (Actual)
Study Completion Date
October 5, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Researchers are trying to determine whether arterial stiffness detected by ultrasound can predict outcomes in the development and recurrence of atrial fibrillation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Carotid Ultrasound testing before and after a clinically scheduled cardioversion procedure.
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Subjects with atrial fibrillation
Arm Type
Experimental
Arm Description
Subjects with atrial fibrillation that have been clinically scheduled for an electrical cardioversion procedure will have carotid ultrasound testing done before and after the procedure
Intervention Type
Diagnostic Test
Intervention Name(s)
Carotid Ultrasound
Intervention Description
Uses sound waves to examine the blood flow through the carotid arteries and to determine the elastic properties or stiffness of the artery.
Primary Outcome Measure Information:
Title
Recurrence of Atrial Fibrillation following cardioversion
Description
We will follow up by phone or look through medical records to record the number of subjects that have had a recurrence of Atrial Fibrillation. We are also looking if we can correlate the recurrence with arterial stiffness.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Occurrence of heart failure
Description
Number of subjects to have heart failure following cardioversion
Time Frame
6 months
Title
Occurrence of stroke
Description
Number of subjects to have a stroke following cardioversion
Time Frame
6 months
Title
Occurrence of hospitalization
Description
Number of subjects that have been hospitalized following cardioversion
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All patients with persistent AF, scheduled for electrical cardioversion
Exclusion Criteria:
Unable to provide informed consent.
Patients with intramural thrombus or other conditions that preclude the performance of electrical cardioversion.
Patients with prior carotid stents.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hon-Chi Lee, MD, PhD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Arterial Stiffness and Atrial Fibrillation
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