UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057561 |
|---|---|
| Receipt number | R000065272 |
| Scientific Title | The Management of Coronary Artery Disease in Patients with Severe Aortic Stenosis Undergoing Transcatheter Aortic Valve Implantation: A Single-Center Retrospective Study |
| Date of disclosure of the study information | 2025/04/10 |
| Last modified on | 2025/04/09 12:43:39 |
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Basic information
Public title
Evaluation of Whether Coronary Artery Disease Should Be Treated First in Patients with Severe Aortic Stenosis and Concomitant Coronary Artery Disease
Acronym
Priority of CAD Treatment in Severe AS
Scientific Title
The Management of Coronary Artery Disease in Patients with Severe Aortic Stenosis Undergoing Transcatheter Aortic Valve Implantation: A Single-Center Retrospective Study
Scientific Title:Acronym
Management of CAD in Patients with Severe AS Undergoing TAVI
Region
| Japan |
Condition
Condition
Aortic Stenosis
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Transcatheter aortic valve implantation (TAVI) is an established standard treatment for elderly patients with severe aortic stenosis (AS). Approximately 50% of AS patients have concomitant coronary artery disease (CAD), but the optimal treatment strategy remains unclear. This study aims to evaluate the optimal management of concomitant CAD and its clinical outcomes.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
A major adverse cardiac event (MACE), defined as all-cause death, myocardial infarction (MI), or unplanned revascularization (PCI or CABG)
Key secondary outcomes
1) All-cause death
2) Myocardial infarction
3) Unplanned revascularization (percutaneous coronary intervention or coronary artery bypass grafting)
4) Bleeding event
5) Stroke
6) Heart failure re-hospitalization
7) Procedural-related clinical complication
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 severe aortic stenosis and coronary artery disease who underwent transcatheter aortic valve implantation from October 2013 to July 2023
Key exclusion criteria
Patients with acute coronary syndrome, a prior history of coronary artery bypass grafting, or those who have undergone transcatheter aortic valve implantation using the valve-in-valve technique
Target sample size
220
Research contact person
Name of lead principal investigator
| 1st name | Futoshi |
| Middle name | |
| Last name | Yamanaka |
Organization
Shonan Kamakura General Hospital
Division name
Department of Cardiology
Zip code
2478533
Address
1370-1, Okamoto, Kamakura, Kanagawa, JAPAN
TEL
0467461717
futoshi.yamanaka@gmail.com
Public contact
Name of contact person
| 1st name | Futoshi |
| Middle name | |
| Last name | Yamanaka |
Organization
Shonan Kamakura General Hospital
Division name
Department of Cardiology
Zip code
2478533
Address
1370-1, Okamoto, Kamakura, Kanagawa, JAPAN
TEL
0467461717
Homepage URL
futoshi.yamanaka@gmail.com
Sponsor or person
Institute
Shonan Kamakura General Hospital
Institute
Department
Personal name
Funding Source
Organization
Shonan Kamakura General Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokushukai Group Institutional Review Board
Address
Emina Building 3F, 1-8-7, Koji-machi, Chiyoda-ku, Tokyo, JAPAN
Tel
03-3263-4801
mirai-ec1@mirai-iryo.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
湘南鎌倉総合病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 04 | Month | 10 | 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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 02 | Month | 03 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 03 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 03 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A single-center retrospective study
Management information
Registered date
| 2025 | Year | 04 | Month | 09 | Day |
Last modified on
| 2025 | Year | 04 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065272
