A Study to Evaluate Reducing Stroke by Screening for Undiagnosed Atrial Fibrillation in Elderly Individuals
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 19-012705
- La Crosse, Wisconsin: 19-012705
- Eau Claire, Wisconsin: 19-012705
About this study
The purpose of this study is to determine if an atrial fibillation (AF) detection intervention in men and women at least 70 years of age with undiagnosed AF or atrial flutter (AFL) reduces the person-years incidence rate of stroke compared to usual care (no AF detection intervention).
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria
- Men and women, ≥ 70 years of age.
- New or established patients in the primary care practice.
- Willing to provide consent to participate in the study and to use personal health information to ascertain endpoints from the CMS Medicare Claims Database and to access data from health records.
- Health insurance by Medicare Parts A & B (Medicare Fee-for-service).
Exclusion Criteria:
- Oral anticoagulation (OAC) for any indication at the time of enrollment.
- History of atrial fibrillation (AF) or atrial flutter (AFL) as documented in the patient’s current medical problem list.
- Any condition the investigator considers a contraindication to OAC; e.g., bleeding that required medical attention or severe renal impairment.
- Any condition the investigator considers will prevent compliance with study instructions.
- Implanted cardiac devices (pacemakers, implantable cardiac defibrillators, or cardiac resynchronization therapy, and implantable loop recorders).
- History of allergy to adhesive.
- Patient is not able to wear the Zio®XT monitor or not able to apply the monitor by herself/himself or with the help of a caregiver
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator David Rushlow, M.D. |
Closed for enrollment |
|
La Crosse, Wis.
Mayo Clinic principal investigator Jacob Erickson, D.O. |
Closed for enrollment |
|
Eau Claire, Wis.
Mayo Clinic principal investigator Steven Rosas, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available