Arterial Stiffness and Atrial Fibrillation

January 13, 2023 updated by: Hon-Chi Lee, M.D., Ph.D., Mayo Clinic
Researchers are trying to determine whether arterial stiffness detected by ultrasound can predict outcomes in the development and recurrence of atrial fibrillation.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Subjects with atrial fibrillation
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
Diagnostic test: Carotid Ultrasound
Uses sound waves to examine the blood flow through the carotid arteries and to determine the elastic properties or stiffness of the artery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence of Atrial Fibrillation following cardioversion
Time Frame: 6 months
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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence of heart failure
Time Frame: 6 months
Number of subjects to have heart failure following cardioversion
6 months
Occurrence of stroke
Time Frame: 6 months
Number of subjects to have a stroke following cardioversion
6 months
Occurrence of hospitalization
Time Frame: 6 months
Number of subjects that have been hospitalized following cardioversion
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Hon-Chi Lee, MD, PhD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 29, 2019

Primary Completion (Actual)

October 5, 2020

Study Completion (Actual)

October 5, 2020

Study Registration Dates

First Submitted

October 31, 2019

First Submitted That Met QC Criteria

November 8, 2019

First Posted (Actual)

November 13, 2019

Study Record Updates

Last Update Posted (Estimate)

January 16, 2023

Last Update Submitted That Met QC Criteria

January 13, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19-005443

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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