UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038396 |
|---|---|
| Receipt number | R000043752 |
| Scientific Title | Gender difference in long-term clinical outcomes after rotational atherectomy in severely calcified coronary stenoses - from J2T multicenter registry - |
| Date of disclosure of the study information | 2019/10/28 |
| Last modified on | 2019/10/29 10:57:15 |
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Basic information
Public title
Gender difference in long-term clinical outcomes after rotational atherectomy in severely calcified coronary stenoses - from J2T multicenter registry -
Acronym
Gender difference in long-term clinical outcomes after rotational atherectomy - from J2T multicenter registry -
Scientific Title
Gender difference in long-term clinical outcomes after rotational atherectomy in severely calcified coronary stenoses - from J2T multicenter registry -
Scientific Title:Acronym
Gender difference in long-term clinical outcomes after rotational atherectomy - from J2T multicenter registry -
Region
| Japan |
Condition
Condition
Patients who underwent percutaneous coronary intervention with rotational atherectomy
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine gender differences in long-term clinical prognosis after percutaneous coronary intervention with rotational atherectomy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Major adverse cardiovascular and cerebrovascular event (any death, acute coronary syndrome, stroke)
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 who underwent percutaneous coronary intervention with rotational atherectomy in Tokyo Women's Medical University, Juntendo University School of Medicine or Teikyo University School of Medicine between January 2004 and December 2015.
Key exclusion criteria
Patients receiving regular hemodialysis
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Nobuhisa |
| Middle name | |
| Last name | Hagiwara |
Organization
Tokyo Women's Medical University
Division name
Department of Cardiology
Zip code
162-8666
Address
8-1 Kawatacho, Shinjyuku-ku, Tokyo, Japan,162-8666
TEL
+813-3353-8111
mhagi@hij.twmu.ac.jp
Public contact
Name of contact person
| 1st name | HISAO |
| Middle name | |
| Last name | OTSUKI |
Organization
Tokyo Women's Medical University
Division name
Department of Cardiology
Zip code
162-8666
Address
8-1 Kawatacho, Shinjyuku-ku, Tokyo, Japan,162-8666
TEL
+813-3353-8111
Homepage URL
h.otsuki0107@gmail.com
Sponsor or person
Institute
Tokyo Women's Medical University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Women's Medical University
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
Tokyo Women's Medical University
Address
8-1 Kawatacho, Shinjyuku-ku, Tokyo, Japan,162-8666
Tel
+813-3353-8111
krinri.bm@twmu.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
| 2019 | Year | 10 | Month | 28 | 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
788
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
Completed
Date of protocol fixation
| 2017 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 11 | Month | 29 | Day |
Anticipated trial start date
| 2017 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Gender difference was not observed in the long-term MACE in patients following PCI with RA against severe calcified coronary artery stenosis.
Management information
Registered date
| 2019 | Year | 10 | Month | 27 | Day |
Last modified on
| 2019 | Year | 10 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043752
