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:
2025-12-24 @ 6:48 PM
Ignite Modification Date:
2025-12-24 @ 6:48 PM
NCT ID:
NCT00166257
Eligibility Criteria:
Inclusion Criteria:
* Age below 60 years
* Ischemic stroke or peripheral thromboembolism, radiologically verified
* Absence of an identifiable cause of embolism
* Echocardiographically verified patent foramen ovale
* Sufficient recovery from index event to allow independent daily activities
Exclusion Criteria:
* Any identifiable cause for thromboembolic event other than PFO
* Cardiac diseases: mural thrombus, dilated cardiomyopathy, prosthetic heart valve or mitral stenosis, endocarditis, atrial fibrillation
* Vascular system: significant atherosclerosis or dissection of the aorta, collagen vascular disease, arteritis, vasculitis
* Pre-existing neurologic disorders or intracranial disease, e.g., multiple sclerosis, arteriovenous malformations, previous hemorrhage
* Contraindications for antithrombotic or anticoagulant therapy
* Patients already on chronic anticoagulant therapy for another disease
* Previous surgical or percutaneous PFO-closure
* Drug or alcohol abuse
* Pregnancy
* Septicemia or severe infectious disease
* Severe CNS disease
* No informed consent
* Foreseen difficulties with study compliance, especially the long-term follow-up
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT00166257
Study Brief:
Protocol Section:
NCT00166257