UMIN-CTR Clinical Trial

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
Email	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
Email	d-takahashi@juntendo.ac.jp

Sponsor
Institute	Juntendo University
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054132