Registry of Endovascular Closure of Patent Foramen Ovale in Russia
Russian Registry of Endovascular Closure of Patent Foramen Ovale
This study is looking at how closing a small hole in the heart called a patent foramen ovale (PFO) affects people over 18 who have had unexplained strokes, to see if it can help improve their health.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 700 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | National Medical Research Center for Cardiology, Ministry of Health of Russian Federation Government |
| Locations | 1 site (Moscow) |
| Trial ID | NCT06156670 on ClinicalTrials.gov |
What this trial studies
This observational study involves patients over 18 years old who have undergone endovascular closure of a patent foramen ovale (PFO) across 29 medical centers in the Russian Federation. It aims to gather data on the relationship between PFO and cryptogenic strokes, which are strokes of undetermined origin. Participants will provide informed consent and personal data as part of their inpatient medical care. The study seeks to enhance understanding of PFO's role in ischemic events and improve patient outcomes.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 who have experienced ischemic events linked to a PFO and can provide informed consent.
Not a fit: Patients who cannot receive antiplatelet therapy or have acute inflammatory diseases will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better management and treatment strategies for patients with cryptogenic strokes associated with PFO.
How similar studies have performed: Other studies have indicated a significant association between PFO and cryptogenic strokes, suggesting that this approach is supported by existing literature.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients with an ischemic event (cryptogenic ischemic stroke, transient ischemic attack, embolism of other organs and systems) associated with a PFO; 2. Presence of an open oval confirmed by ultrasound diagnostic methods; 3. Age of patients from 18 years; 4. Life expectancy of at least 1 year; 5. Signed informed consent for endovascular closure of a PFO. Exclusion Criteria: 1. Inability to receive antiplatelet therapy; 2. Presence of acute inflammatory diseases; 3. Acute stage of cerebral circulatory failure (30 days); 4. Myocardial infarction or aortocoronary bypass surgery within the previous 30 days; 5. Carotid or vertebral artery dissection; 6. Severe cardiac valve pathology; 7. Presence of blood clots in the cardiac cavities; 8. Refusal of the patient to participate in the study.
Where this trial is running
Moscow
- National Medical Research Center for Cardiology, Ministry of Health of Russian Federation — Moscow, Russia (Recruiting)
Study contacts
- Study coordinator: Andrey Tereschenko
- Email: andrew034@yandex.ru
- Phone: 84954150144
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.