Atrial FibrillationNCT04160663
Arterial Stiffness and Atrial Fibrillation
A study testing Carotid Ultrasound in people with Atrial Fibrillation, run by Mayo Clinic at 1 site in United States.
Trial summary
Researchers are trying to determine whether arterial stiffness detected by ultrasound can predict outcomes in the development and recurrence of atrial fibrillation. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Carotid Ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Oct 2019to 5 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients with persistent AF, scheduled for electrical cardioversion
Who cannot join
- Unable to provide informed consent.
- Patients with intramural thrombus or other conditions that preclude the performance of electrical cardioversion.
- Patients with prior carotid stents.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
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
- Being tested
- Carotid Ultrasound
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carotid UltrasoundDiagnostic test
Uses sound waves to examine the blood flow through the carotid arteries and to determine the elastic properties or stiffness of the artery.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: Carotid Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (3)
Occurrence of heart failure
Number of subjects to have heart failure following cardioversion
Measured: 6 months
Occurrence of stroke
Number of subjects to have a stroke following cardioversion
Measured: 6 months
Occurrence of hospitalization
Number of subjects that have been hospitalized following cardioversion
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2019
- Study start29 Oct 2019
- Primary completion5 Oct 2020
- Study completion5 Oct 2020
Why it stopped: Due to COVID and staffing issues study was terminated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Carotid Ultrasound testing before and after a clinically scheduled cardioversion procedure.
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hon-Chi Lee, M.D., Ph.D., Mayo Clinic
- Investigators
- Hon-Chi Lee, MD, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04160663
- Sponsor's protocol ID
- 19-005443
- Status last verified
- Jan 2023
- First submitted
- 31 Oct 2019
- Last updated
- 17 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arterial Stiffness and Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT04160663
- Acronym / sponsor ID
- 19-005443
- Conditions
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to COVID and staffing issues study was terminated
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 29 Oct 2019 (actual)
- Primary completion
- 5 Oct 2020 (actual)
- Study completion
- 5 Oct 2020 (actual)
- First posted
- 13 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Researchers are trying to determine whether arterial stiffness detected by ultrasound can predict outcomes in the development and recurrence of atrial fibrillation.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Carotid Ultrasound testing before and after a clinically scheduled cardioversion procedure.
| Arm | Type | Receives |
|---|---|---|
| Subjects with atrial fibrillation | Experimental | Diagnostic Test: Carotid UltrasoundSubjects with atrial fibrillation that have been clinically scheduled for an electrical cardioversion procedure will have carotid ultrasound testing done before and after the procedure |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients with persistent AF, scheduled for electrical cardioversion
Key exclusion criteria (3 listed)
- Unable to provide informed consent.
- Patients with intramural thrombus or other conditions that preclude the performance of electrical cardioversion.
- Patients with prior carotid stents.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carotid UltrasoundUses sound waves to examine the blood flow through the carotid arteries and to determine the elastic properties or stiffness of the artery. | Diagnostic test | Subjects with atrial fibrillation |
Primary outcome
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.
3 secondary outcomes
Occurrence of heart failure
Time frame: 6 months
Occurrence of stroke
Time frame: 6 months
Occurrence of hospitalization
Time frame: 6 months
Results and safety
The study was stopped early (reason given: Due to COVID and staffing issues study was terminated). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2023.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Atrial Fibrillation
RecruitingPhase 3
Stroke and Systemic Embolism Prevention in Adult Participants With Atrial Fibrillation
Atrial Fibrillation (AF)
Not yet recruiting
Partial Cardiac Denervation for Preventing Atrial Fibrillation After CABG
Postoperative Atrial Fibrillation, Coronary Artery Disease
Recruiting
Peer-Mentor Support for Vulnerable Patients With Atrial Fibrillation
Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
Not yet recruitingObservational study
Hummingbird ICE Study
ATRIAL APPENDAGE CLOSURE for ATRIAL FIBRILLATION, Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hon-Chi Lee, MD, PhD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carotid Ultrasound in people with Atrial Fibrillation, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Due to COVID and staffing issues study was terminated). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence of Atrial Fibrillation following cardioversion (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2023.