UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Kumamoto University Malignancy and Atheroscrelosis study
Title of the study (Brief title)	KUMA study
Region	Japan

Condition
Condition	Coronary artery disease
Classification by specialty	Cardiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	With progress in medical technology, cardiovascular events in cancer survivors are attracting attention.
Basic objectives2	Others
Basic objectives -Others	We sought to examine whether the differential incidence of cardiovascular events after percutaneous coronary intervention with or without malignant diseases.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	target lesion revascularization(TLR) within 1-year
Key secondary outcomes	total cardiovascular event (cardiovascular death, nonfatal myocardial infarction, unstable angina pectoris, TLR, non TLR revascularization and hospitalization for heart failure decompensation). All-cause death

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	Those who received percutaneous coronary intervention in our department.
Key exclusion criteria	none
Target sample size	1000

Research contact person
Name of lead principal investigator	Daisuke Sueta
Organization	Kumamoto University
Division name	Cardiovacular Medicine
Address	1-1-1 Honjo
TEL	096-373-5175
Email	sueta-d@kumamoto-u.ac.jp

Public contact
Name of contact person	Daisuke Sueta
Organization	Kumamoto University
Division name	Cardiovacular Medicine
Address	1-1-1 Honjo
TEL	096-373-5175
Homepage URL
Email	sueta-d@kumamoto-u.ac.jp

Sponsor
Institute	Cardiovacular Medicine, Kumamoto University
Institute
Department

Funding Source
Organization	self funding
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 08 Month 20 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2007 Year 01 Month 01 Day
Anticipated trial start date	2007 Year 01 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	Published
URL releasing results
Results
Other related information	none

Management information
Registered date	2017 Year 08 Month 13 Day
Last modified on	2018 Year 02 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032793