Dual ultrasound screening by heart brain team to improve the detection of PFO in cryptogenic stroke patients

Dual Screening Combining Transthoracic Echocardiography and Transcranial Doppler by Heart Brain Team for Detecting Patent Foramen Ovale in Patients with Cryptogenic Stroke - DUPLEX-PFO study (DUal screening by transthoracic echocardiography and transcranial Doppler for PFO in cryptogenic stroke)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000060079

Enrollment

400

Registered

2025-12-14

Start date

2025-11-27

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cryptogenic stroke

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients diagnosed by stroke specialists as having ischemic stroke or transient ischemic attack (TIA) suspected to be cryptogenic or possibly related to patent foramen ovale (PFO). Patients who underwent both transthoracic echocardiography (TTE) and transcranial Doppler (TCD) bubble tests as part of the diagnostic screening for PFO. Patients who also underwent transesophageal echocardiography (TEE) for definitive confirmation of PFO. Age over than 10 years. Sufficient clinical and echocardiographic data available for retrospective analysis.

Exclusion criteria

Exclusion criteria: Patients who did not undergo either transthoracic echocardiography (TTE) or transcranial Doppler (TCD) bubble test. Patients in whom transesophageal echocardiography (TEE) was not performed or yielded inadequate imaging for confirmation of PFO. Cases with technically inadequate TTE or TCD images, or insufficient visualization for bubble counting. Patients with other known causes of right-to-left shunt (e.g., pulmonary arteriovenous malformation, atrial septal defect) unrelated to PFO. Patients with severe comorbid conditions (e.g., advanced heart failure, malignancy) in whom standard screening was not completed. Incomplete clinical or echocardiographic data precluding accurate analysis.

Design outcomes

Primary

Measure	Time frame
The primary outcome is the diagnostic accuracy of combined transthoracic echocardiography (TTE) and transcranial Doppler (TCD) bubble tests for detecting patent foramen ovale (PFO), using transesophageal echocardiography (TEE) as the reference standard. Diagnostic performance will be assessed by sensitivity, specificity, overall accuracy, and the area under the receiver operating characteristic curve (AUC). Incremental diagnostic value of adding TCD to TTE will be evaluated using a sequential logistic regression model.	—

Measure

Time frame

The primary outcome is the diagnostic accuracy of combined transthoracic echocardiography (TTE) and transcranial Doppler (TCD) bubble tests for detecting patent foramen ovale (PFO), using transesophageal echocardiography (TEE) as the reference standard. Diagnostic performance will be assessed by sensitivity, specificity, overall accuracy, and the area under the receiver operating characteristic curve (AUC). Incremental diagnostic value of adding TCD to TTE will be evaluated using a sequential logistic regression model.

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Countries

Japan

Contacts

Public ContactYasuhide Mochizuki

Showa medical university Division of Cardiology, Department of Medicine, Showa Medical University School of Medicine

yasuhide820@hmail.com03-3784-8000

Outcome results