Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:48 AM
Ignite Modification Date:
2025-12-25 @ 4:48 AM
NCT ID:
NCT04285918
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Years
Study:
NCT04285918
Study Brief:
Protocol Section:
NCT04285918