UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048607 |
|---|---|
| Receipt number | R000055384 |
| Scientific Title | Long-Term Prognoses of Patients with and without de novo Coronary Stenosis in Left Anterior Descending Artery Stenosis in the Drug Eluting Stent era |
| Date of disclosure of the study information | 2022/08/16 |
| Last modified on | 2022/08/05 17:30:59 |
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Basic information
Public title
Long-Term Prognoses of Patients with and without de novo Coronary Stenosis in Left Anterior Descending Artery Stenosis in the Drug Eluting Stent era
Acronym
Long-Term Prognoses of Patients with and without de novo Coronary Stenosis in LAD Artery Stenosis in the DES era
Scientific Title
Long-Term Prognoses of Patients with and without de novo Coronary Stenosis in Left Anterior Descending Artery Stenosis in the Drug Eluting Stent era
Scientific Title:Acronym
Long-Term Prognoses of Patients with and without de novo Coronary Stenosis in LAD Artery Stenosis in the DES era
Region
| Japan |
Condition
Condition
coronary artery disease
Classification by specialty
| Cardiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the differences in baseline profiles and the prognosis between CAD patients with and without LAD lesions
Basic objectives2
Others
Basic objectives -Others
Prognostic comparison of each patient
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
major adverse cardiac event
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
New coronary artery disease patients
Key exclusion criteria
Patients with previously documented coronary artery disease. Patients who have undergone previous coronary revascularization.
Target sample size
1200
Research contact person
Name of lead principal investigator
| 1st name | Junichi |
| Middle name | |
| Last name | Yamaguchi, |
Organization
Tokyo Womens Medical University
Division name
Department of Cardiology
Zip code
162-0054
Address
8-1 Kawadacho, Shinjuku-ku, Tokyo, Japan
TEL
03-3353-8111
jyamaguchi0110@gmail.com
Public contact
Name of contact person
| 1st name | Kentaro |
| Middle name | |
| Last name | Jujo |
Organization
Saitama Medical Center
Division name
Department of Cardiology
Zip code
350-8550
Address
1981 Kamoda, Kawagoe, Saitama
TEL
0492-28-3400
Homepage URL
juken1123@mac.com
Sponsor or person
Institute
Tokyo Womens Medical University
Institute
Department
Personal name
Funding Source
Organization
none
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
Tokyo Womens Medical University
Address
8-1 Kawadacho, Shinjuku-ku, Tokyo, Japan
Tel
03-3353-8111
juken1123@mac.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
| 2022 | Year | 08 | Month | 16 | 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
1245
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
No longer recruiting
Date of protocol fixation
| 2014 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 05 | Month | 01 | Day |
Anticipated trial start date
| 2015 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
cohort study
Management information
Registered date
| 2022 | Year | 08 | Month | 05 | Day |
Last modified on
| 2022 | Year | 08 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055384
