UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000047470 |
|---|---|
| Receipt number | R000054132 |
| Scientific Title | assessment of aortic valve calcification on ECG-gated non-contrast CT |
| Date of disclosure of the study information | 2022/04/18 |
| Last modified on | 2022/04/12 17:56:29 |
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Basic information
Public title
assessment of aortic valve calcification on ECG-gated non-contrast CT
Acronym
assessment of aortic valve calcification on ECG-gated non-contrast CT
Scientific Title
assessment of aortic valve calcification on ECG-gated non-contrast CT
Scientific Title:Acronym
assessment of aortic valve calcification on ECG-gated non-contrast CT
Region
| Japan |
Condition
Condition
Aortic stenosis(AS)
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study is conducted to evaluate the efficacy of assessing AVC on ECG-gated non-contrast CT in predicting AS progression and cardiovascular events, over conventional assessment with TEE.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
All cause death and cardiovascular events, consisted of cardiac death, invasive intervention, and hospitalization due to heart failure.
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
| 65 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who had been diagnosed moderate or severe aortic stenosis by echocardiography, and who was not going to undergo invasive treatment.
Key exclusion criteria
1. Poor image quality
2. Congenital abnormality of heart or aorta
3. Planned revasularization
4. End stage kidney disease
5. Abnormal calcium metabolism
6. Un-controlled heart failure
7. Others
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Fujimoto |
| Middle name | |
| Last name | Shinichiro |
Organization
Juntendo University Graduate School of Medicine
Division name
Department of Cardiovasuclar Biology and Medicine
Zip code
1138421
Address
2-1-1, Hongo, Bunkyo-ku, Tokyo
TEL
0338133111
snfujimo@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Takahashi |
| Middle name | |
| Last name | Daigo |
Organization
Juntendo University Graduate School of Medicine
Division name
Department of Cardiovasuclar Biology and Medicine
Zip code
1138421
Address
2-1-1, Hongo, Bunkyo-ku, Tokyo
TEL
0338133111
Homepage URL
d-takahashi@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
Edwards Lifesciences
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Juntendo University Graduate School of Medicine
Address
2-1-1, Hongo, Bunkyo-ku, Tokyo
Tel
0338133111
d-takahashi@juntendo.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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 04 | Month | 18 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
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
Preinitiation
Date of protocol fixation
| 2022 | Year | 03 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Evaluation of CT-derived aortic valve calcification and its change over 2-year.
Management information
Registered date
| 2022 | Year | 04 | Month | 12 | Day |
Last modified on
| 2022 | Year | 04 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054132
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
