Internal Microstructure of Patent Foramen Ovale Related to Stroke

  • STATUS
    Recruiting
  • End date
    Dec 31, 2025
  • participants needed
    300
  • sponsor
    China National Center for Cardiovascular Diseases
Updated on 28 April 2021

Summary

This study aims to (1) investigate the internal microstructure of patent foramen ovale related to cryptogenic stroke, transient ischemic attack or migraine and determine the effectiveness of transcatheter closure in these patients; (2) evaluate the microstructural features of asymptomatic patients with PFO and make a follow-up.

Description

Patent foramen ovale (PFO) is associated with a variety of pathological conditions, and it is presumed to be related to the occurrence of cryptogenic stroke (CS), transient ischemic attack (TIA) or migraine. In addition, the main hypothesized pathophysiologic mechanism is paradoxical embolization, namely microemboli or metabolites from the venous circulation to enter the systemic circulation. The morphological characteristics of PFO have the potential to predict risks and screen the appropriate candidates for transcatheter closure. The structure features for predicting risk included atrial septal aneurysm, a large right-left shunt, long-tunnel PFO and so on. However, the in-vivo internal microstructure of PFO is still unclear. The microstructural features might provide important information for better understanding the PFO and risk stratification.

The aim of this study is to (1) investigate the internal microstructure of patent foramen ovale related to cryptogenic stroke, transient ischemic attack or migraine and determine the effectiveness of transcatheter closure in these patients; (2) evaluate the microstructural features of asymptomatic patients with PFO and make a follow-up.

This study will enroll subjects with PFO, and enrollment will be divided into three phases.

Phase 1: PFO patients with CS or/and TIA (transcatheter closure of PFO was performed). A minimum of 100 patients is reached.

Phase 2: PFO patients with migraine (transcatheter closure of PFO was performed). A minimum of 100 patients is reached.

Phase 3: PFO patients without symptom (5-year follow-up). A minimum of 100 patients is reached.

Details
Condition Patent foramen ovale, ostium secundum atrial septal defect
Treatment not appliable
Clinical Study IdentifierNCT04686253
SponsorChina National Center for Cardiovascular Diseases
Last Modified on28 April 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients aged 16 to 65 years without any known vascular risk factor, including hypertension, hypercholesterolemia, diabetes mellitus, atrial fibrillation, smoking and obesity
Documented PFO with right-to-left shunt 20 micro-bubbles by c-TCD
Stroke group: history of ischemic stroke (based on brain magnetic resonance imaging) or TIA within 6 months without other identifiable causes (Phase1)
Migraine group: history of migraine headaches more than one year without other identifiable causes (Phase2)
Control group: incidental finding of PFO without neurological or systemic symptoms (Phase3)

Exclusion Criteria

Any identifiable cause of ischemic stroke/TIA or migraine other than PFO
Presence of cardiac enlargement or dysfunction
Presence of coexisting cardiovascular structural malformations/diseases
Presence of carotid artery lesions or coronary artery disease
Presence of deep vein thrombosis or pulmonary embolism
History of stroke or TIA within the past one month
Presence of implanted cardiac devices
Evidence of hypercoagulable state
Allergic to contrast medium
Echocardiographic evidence of intra-cardiac thrombus, mass, tumor or vegetation
Active endocarditis or other infections
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