UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030517
Receipt number 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 12:19:06

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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 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


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

Value
https://center6.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