Internal Microstructure of Patent Foramen Ovale Related to Stroke

Launched by CHINA NATIONAL CENTER FOR CARDIOVASCULAR DISEASES · Dec 23, 2020

Keywords

ClinConnect Summary

This clinical trial is studying a condition called patent foramen ovale (PFO), which is a small opening in the heart that can sometimes lead to strokes, transient ischemic attacks (TIAs), or migraines. The researchers want to understand the internal structure of this opening, especially in patients who have had a stroke or migraine and to see if a procedure called transcatheter closure, which helps close the PFO, is effective. They will also look at people who have PFO but do not have any symptoms to compare their results.

To be eligible for this study, you should be between 16 and 65 years old and have no known health issues that might increase your risk for stroke or other related conditions. You’ll need to have a documented PFO and either a history of a stroke or TIA within the last six months or a history of migraines for more than a year. Participants will undergo various tests, including imaging and blood samples, to help the researchers gather important information. This study is currently looking for participants, and it aims to provide valuable insights into how PFO affects health and the potential benefits of treating it.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients aged 16 to 65 years without any known vascular risk factor, including hypertension, hypercholesterolemia, diabetes mellitus, atrial fibrillation, smoking and obesity;
• • 2. Documented PFO with right-to-left shunt ≥ 20 micro-bubbles by c-TCD;
• • 3. Stroke group: history of ischemic stroke (based on brain magnetic resonance imaging) or TIA within 6 months without other identifiable causes (Phase1);
• • 4. Migraine group: history of migraine headaches more than one year without other identifiable causes (Phase2);
• • 5. Control group: incidental finding of PFO without neurological or systemic symptoms (Phase3).
• Exclusion Criteria:
• • 1. Any identifiable cause of ischemic stroke/TIA or migraine other than PFO;
• • 2. History of stroke or TIA within the past one month;
• • 3. Presence of cardiac enlargement or dysfunction;
• • 4. Presence of coexisting cardiovascular structural malformations/diseases;
• • 5. Presence of carotid artery lesions or coronary artery disease;
• • 6. Presence of deep vein thrombosis or pulmonary embolism;
• • 7. Presence of implanted cardiac devices;
• • 8. Evidence of hypercoagulable state;
• • 9. Allergic to contrast medium;
• • 10. Echocardiographic evidence of intra-cardiac thrombus, mass, tumor or vegetation;
• • 11. Active endocarditis or other infections.