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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030517
Receipt No. R000034833
Scientific Title Predictors of long-term cardiovascular mortality after rotational atherectomy in patients with regular hemodialysis - from J2T multicenter registry -
Date of disclosure of the study information 2017/12/22
Last modified on 2017/12/22

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Basic information
Public title Predictors of long-term cardiovascular mortality after rotational atherectomy in patients with regular hemodialysis - from J2T multicenter registry -
Acronym Predictors of CV mortality after rotational atherectomy in HD patients - from J2T multicenter registry -
Scientific Title Predictors of long-term cardiovascular mortality after rotational atherectomy in patients with regular hemodialysis - from J2T multicenter registry -
Scientific Title:Acronym Predictors of CV mortality after rotational atherectomy in HD patients - from J2T multicenter registry -
Region
Japan

Condition
Condition Patients who underwent percutaneous coronary intervention with rotational atherectomy
Classification by specialty
Cardiology Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To identify clinical and procedural features predicting long-term clinical prognosis of hemodialysis patients after percutaneous coronary intervention (PCI) with rotational atherectomy (RA).
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Cardiovascular death
Key secondary outcomes Major adverse cardiovascular event (any death, acute coronary syndrome, stent thrombosis, stroke, target vessel revascularization)

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
30 years-old <=
Age-upper limit
90 years-old >=
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 N/A
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nobuhisa Hagiwara
Organization Tokyo Women's Medical University
Division name Department of Cardiology
Zip code
Address 8-1 Kawatacho, Shinjyuku-ku, Tokyo, Japan,162-8666
TEL +813-3353-8111
Email mhagi@hij.twmu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kentaro Jujo
Organization Tokyo Women's Medical University
Division name Department of Cardiology
Zip code
Address 8-1 Kawatacho, Shinjyuku-ku, Tokyo, Japan,162-8666
TEL +813-3353-8111
Homepage URL
Email juken1123@mac.com

Sponsor
Institute Tokyo Women's Medical University
Institute
Department

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
Address
Tel
Email

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
2017 Year 12 Month 22 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 Completed
Date of protocol fixation
2017 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information During observational period, cardiovascular death was observed in 19.5% of hemodialysis group, that was significantly worse than Non-hemodialysis group (7.5%, p<0.001).

Management information
Registered date
2017 Year 12 Month 22 Day
Last modified on
2017 Year 12 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034833

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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