Clinical trial NCT04285918: Evaluation of Prevalence and Clinical Impact of Atrial Fibrillation in Elderly Patients With Cryptogenic Stroke and High-Risk Patent Foramen Ovale
Official title: Evaluation of Prevalence and Clinical Impact of Atrial Fibrillation in Elderly Patients With Cryptogenic Stroke and High-Risk Patent Foramen Ovale
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cryptogenic Stroke
High Risk Patent Foramen Ovale
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2020-02-26
Enrollment: 300
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients ≥60 y/o with ESUS and PFO that is likely to have causative role (high-risk anatomical feature) (cohort A) and Patients ≥60 y/o with ESUS without PFO, or with non-high risk PFO (cohort B)

Brief summary: The purpose of DEFENSE-ELDERLY is to identify the prevalence of AF and evaluate the clinical impact of AF in elderly ESUS patients and no other known sources of stroke besides a high-risk patent foramen ovale, and compare it with elderly ESUS patients without high-risk PFO (no PFO or non-high risk PFOs)

Detailed description: The purpose of DEFENSE-ELDERLY is to identify the prevalence of AF and evaluate the clinical impact of AF in elderly ESUS patients and no other known sources of stroke besides a high-risk patent foramen ovale, and compare it with elderly ESUS patients without high-risk PFO (no PFO or non-high risk PFOs)

Eligibility criteria: Inclusion Criteria:

* Patients ≥60 y/o with ESUS and PFO that is likely to have causative role (high-risk anatomical feature) (cohort A)
* Patients ≥60 y/o with ESUS without PFO, or with non-high risk PFO (cohort B)
* The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the institutional review board
* Patients who are scheduled to have implantable cardiac monitoring

Exclusion Criteria:

* Transient ischemic attack
* Lacunar infarction (infarction at subcortical area with a lesion diameter less than 2cm on MR)
* Presence of complex aortic atheroma (≥4mm in plaque thickness or presence of mobile components)
* Presence of ≥50% luminal stenosis (extra- or intracranial) in arteries supplying the ischemic area
* Unwillingness or inability to comply with the procedures described in this protocol
* Life expectancy \< 1 years for any non-cardiac or cardiac causes

Primary outcomes:
measure: Paroxysmal AF episodes > 30 seconds detected with intermittent recordings or ≥ 2 minutes during ICM within 6 months
timeFrame: Enrollment to 6 months
Secondary outcomes:
measure: Paroxysmal AF episodes > 30 seconds detected with intermittent recordings or ≥ 2 minutes during ICM within 36 months
timeFrame: Enrollment to 36 months
measure: Paroxysmal AF episodes > 30 seconds detected with intermittent recordings or ≥ 6 minutes during ICM at 6 months and 36 months
timeFrame: 6 months to 36 months
measure: Rates of percutaneous device closure, prescription of anticoagulants (warfarin or direct oral anticoagulants)
timeFrame: Enrollment to 36 months
measure: Recurrent stroke or TIA
timeFrame: Enrollment to 36 months
measure: All-cause death, Vascular Death
timeFrame: Enrollment to 36 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
References: