UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053132 |
|---|---|
| Receipt number | R000060638 |
| Scientific Title | Investigation of factors associated with left atrial appendage dysfunction |
| Date of disclosure of the study information | 2023/12/17 |
| Last modified on | 2025/06/18 19:17:42 |
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Basic information
Public title
Investigation of factors associated with left atrial appendage dysfunction
Acronym
Investigation of factors associated with left atrial appendage function
Scientific Title
Investigation of factors associated with left atrial appendage dysfunction
Scientific Title:Acronym
Investigation of factors associated with left atrial appendage function
Region
| Japan |
Condition
Condition
Atrial fibrillation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Among patients with atrial fibrillation who are considered to be at low thrombotic risk, factors associated with thrombogenic risk findings will be comprehensively investigated.
Basic objectives2
Others
Basic objectives -Others
Among patients with atrial fibrillation who are considered to be at low thrombotic risk, factors associated with thrombogenic risk findings will be comprehensively investigated.
Trial characteristics_1
Others
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Transesophageal echocardiographic findings of thrombogenic milieu in the left atrial appendage
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with atrial fibrillation undergoing transthoracic and transesophageal echocardiography
Patients with CHA2DS2-VASc scores 0 to 2
Key exclusion criteria
Patients with hypertrophic cardiomyopathy
Patients who have undergone left atrial appendage closure or resection or ligation
Patients with CHA2DS2-VASc scores of 3 or higher
Target sample size
800
Research contact person
Name of lead principal investigator
| 1st name | Tomoko |
| Middle name | |
| Last name | Machino-Ohtsuka |
Organization
University of Tsukuba, Institute of Medicine
Division name
Department of Cardiology
Zip code
3058575
Address
1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
TEL
029-853-3143
tomoko-machino@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Tomoko |
| Middle name | |
| Last name | Machino-Ohtsuka |
Organization
University of Tsukuba, Institute of Medicine
Division name
Department of Cardiology
Zip code
3058575
Address
1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
TEL
029-853-3143
Homepage URL
tomoko-machino@md.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba, Institute of Medicine, Department of Cardiology
Institute
Department
Personal name
Tomoko Machino-Ohtsuka
Funding Source
Organization
Self-funding
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
The Clinical Research Ethics Review Committee of the University of Tsukuba Hospital
Address
1-1-1 Tennnodai, Tsukuba, Ibaraki
Tel
029-853-3914
rinshokenkyu@un.tsukuba.ac.jp
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
筑波大学附属病院（茨城県）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 12 | Month | 17 | Day |
Related information
URL releasing protocol
https://www.sciencedirect.com/science/article/pii/S0167527324013044
Publication of results
Published
Result
URL related to results and publications
https://www.sciencedirect.com/science/article/pii/S0167527324013044
Number of participants that the trial has enrolled
707
Results
LVH independently associated with LAA thrombogenic milieu after adjusting for clinical factors (including CHA2DS2-VASc score, AF type, and serum brain natriuretic peptide levels) and conventional echocardiographic parameters (including LV ejection fraction, LV end-diastolic volume index, and left atrium volume index) . Moreover, LVH provided incremental value for predicting LAA thrombogenic milieu, even when added to the longitudinal strain of the LV and left atrium reservoir strains.
Results date posted
| 2025 | Year | 06 | Month | 18 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Among the 707 participants, 12.2% were women, with an overall mean age of 61years and a mean CHA2DS2-VASc score of 1.2. Overall, 77 (10.9%) patients were classified into the LVH group, and the remaining 630 (89.1%) into the non-LVH group. The LVH group exhibited higher CHA2DS2-VASc scores and a greater prevalence of heart failure and non-paroxysmal AF than the non-LVH group. Direct oral anticoagulants were less commonly administered in the LVH group. The rates of underdosed direct oral anticoagulants and time in the therapeutic range <70% were comparable between both groups.
Participant flow
We screened 1329 consecutive patients who underwent TEE after clinical indications at the University of Tsukuba Hospital between January 2016 and December 2017. The exclusion criteria included patients with no AF history (n = 131), history of percutaneous LAA closure or surgical LAA resection or ligation (n = 24), those with hypertrophic cardiomyopathy (n = 18), and those with CHA2DS2-VASc scores equal or more than 3 (n = 449). Finally, 707 patients with AF and CHA2DS2-VASc scores of 0 to 2 were enrolled in this study.
Adverse events
None
Outcome measures
Multivariable analysis demonstrated that LVH remained a significant independent predictor of LAA thrombogenic milieu, even after adjustment for clinical variables (such as CHA2DS2-VASc score, non-paroxysmal atrial fibrillation, and log-transformed B-type natriuretic peptide), conventional echocardiographic parameters (including LV end-diastolic volume index, left ventricular ejection fraction, and left atrial volume index), and myocardial strain indices (including LV global longitudinal strain, RELAPS, and left atrial reservoir strain). Stepwise modeling further revealed the incremental prognostic value of each variable. In the clinical model, non-paroxysmal AF and BNP added prognostic value beyond the CHA2DS2-VASc score. In the echocardiographic model, LVEF and LAVI added value beyond LVEDVI. Similarly, in the strain-based model, RELAPS and LA reservoir strain improved predictive performance when added to LV-GLS. Importantly, the addition of LVH enhanced the predictive ability across all models, indicating its incremental value beyond both conventional and advanced echocardiographic metrics.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 09 | Month | 20 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 20 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 20 | Day |
Last follow-up date
| 2023 | Year | 10 | Month | 20 | Day |
Date of closure to data entry
| 2024 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2024 | Year | 04 | Month | 01 | Day |
Date analysis concluded
Other
Other related information
Information on cardiac function on transthoracic and transesophageal echocardiography, clinical factors (type and duration of atrial fibrillation, comorbidities, etc.) will be reviewed to investigate factors that may be associated with thrombogenic risk findings in the left atrial appendage.
Management information
Registered date
| 2023 | Year | 12 | Month | 17 | Day |
Last modified on
| 2025 | Year | 06 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060638
