UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Predictors of long-term cardiovascular mortality after rotational atherectomy in patients with regular hemodialysis - from J2T multicenter registry -
Title of the study (Brief title)	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	Nobuhisa Hagiwara
Organization	Tokyo Women's Medical University
Division name	Department of Cardiology
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	Kentaro Jujo
Organization	Tokyo Women's Medical University
Division name	Department of Cardiology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 08 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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