UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060079 |
|---|---|
| Receipt number | R000068242 |
| Scientific Title | Dual Screening Combining Transthoracic Echocardiography and Transcranial Doppler by Heart Brain Team for Detecting Patent Foramen Ovale in Patients with Cryptogenic Stroke |
| Date of disclosure of the study information | 2025/12/14 |
| Last modified on | 2025/12/14 12:43:53 |
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Basic information
Public title
Dual ultrasound screening by heart brain team to improve the detection of PFO in cryptogenic stroke patients
Acronym
DUPLEX-PFO study
(DUal screening by transthoracic echocardiography and transcranial Doppler for PFO in cryptogenic stroke)
Scientific Title
Dual Screening Combining Transthoracic Echocardiography and Transcranial Doppler by Heart Brain Team for Detecting Patent Foramen Ovale in Patients with Cryptogenic Stroke
Scientific Title:Acronym
DUPLEX-PFO study
(DUal screening by transthoracic echocardiography and transcranial Doppler for PFO in cryptogenic stroke)
Region
| Japan |
Condition
Condition
Cryptogenic stroke
Classification by specialty
| Cardiology | Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate whether dual screening combining transthoracic echocardiography (TTE) and transcranial Doppler (TCD) performed by a multidisciplinary heart brain team can improve the diagnostic accuracy for detecting patent foramen ovale (PFO) in patients with cryptogenic stroke, compared with either modality alone.
In particular, the study seeks to clarify the incremental value of combining both modalities in reducing missed diagnoses and to establish an optimal collaborative screening strategy for clinical practice.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
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.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 10 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key 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.
Key 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.
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Yasuhide |
| Middle name | |
| Last name | Mochizuki |
Organization
Showa Medical University
Division name
Division of Cardiology, Department of Medicine, Showa Medical University School of Medicine
Zip code
142-8555
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo,
TEL
03-3784-8000
yasuhide820@gmail.com
Public contact
Name of contact person
| 1st name | Yasuhide |
| Middle name | |
| Last name | Mochizuki |
Organization
Showa medical university
Division name
Division of Cardiology, Department of Medicine, Showa Medical University School of Medicine
Zip code
142-8555
Address
Division of Cardiology, Department of Medicine, Showa Medical University School of Medicine
TEL
03-3784-8000
Homepage URL
yasuhide820@hmail.com
Sponsor or person
Institute
Showa Medical University
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Showa University Hospital Institutional Review Board (IRB)
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo
Tel
03-3784-5000
yasuhide@gmail.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 12 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
399
Results
Among 399 cryptogenic stroke patients undergoing TTE, TCD, and TEE, incremental value of adding TCD to TTE was assessed. Sequential logistic regression showed a significant stepwise increase in model performance. Fifty four patients were positive on either modality, of whom 28% had PFO. The OR strategy improved sensitivity to 96.2%, while the AND strategy increased specificity. Dual TTE and TCD screening reduced missed PFO diagnoses.
Results date posted
| 2025 | Year | 12 | Month | 14 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2025 | Year | 11 | Month | 27 | Day |
Date of IRB
| 2025 | Year | 11 | Month | 27 | Day |
Anticipated trial start date
| 2025 | Year | 11 | Month | 27 | Day |
Last follow-up date
| 2026 | Year | 11 | Month | 27 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
nothing else
Management information
Registered date
| 2025 | Year | 12 | Month | 14 | Day |
Last modified on
| 2025 | Year | 12 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068242
