Arterial Stiffness and Atrial Fibrillation

NCT04160663 | Terminated

• 1 other identifier: 19-005443
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Researchers are trying to determine whether arterial stiffness detected by ultrasound can predict outcomes in the development and recurrence of atrial fibrillation.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (3)

• Occurrence of heart failure

  6 months

• Occurrence of stroke

  6 months

• Occurrence of hospitalization

  6 months

Study Arms (1)

Subjects with atrial fibrillation

EXPERIMENTAL

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

Interventions

Carotid Ultrasound DIAGNOSTIC_TEST

Uses sound waves to examine the blood flow through the carotid arteries and to determine the elastic properties or stiffness of the artery.

Subjects with atrial fibrillation

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients with persistent AF, scheduled for electrical cardioversion

You may not qualify if:

• Unable to provide informed consent.
• Patients with intramural thrombus or other conditions that preclude the performance of electrical cardioversion.
• Patients with prior carotid stents.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Ultrasonography, Carotid Arteries

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ultrasonography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Hon-Chi Lee, MD, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Carotid Ultrasound testing before and after a clinically scheduled cardioversion procedure.

Study Record Dates

• First Submitted: October 31, 2019
• First Posted: November 13, 2019
• Study Start: October 29, 2019
• Primary Completion: October 5, 2020
• Study Completion: October 5, 2020
• Last Updated: January 17, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)