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	The three major causes of death of the Japanese are malignant diseases, heart diseases, cerebrovascular diseases, and with the progress of aging society, opportunities to treat these disease groups tend to increase. Atherosclerotic diseases derived from lifestyle diseases such as myocardial infarction, angina pectoris, peripheral artery disease, aneurysm, cerebral infarction and the like are often conflicting and not coincidental, and in university hospitals with many complicated diseases in particular This tendency is strong, and there are times when you have difficulty in prioritizing treatment. At the present time, the coexistence rate and association of malignant tumor and atherosclerotic disease is not sufficiently clarified.
Basic objectives2	Others
Basic objectives -Others	Coexistence rate of atherosclerotic disease and malignant disease will be clarified by retrospective multidisciplinary collaborative observation research.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	In the patients with malignant disease, the history of the atherosclerosis disease and the morbidity rate are investigated. We also investigate malignant disease complications and past history in patients with atherosclerosis disease.
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	18 years-old <=
Age-upper limit	100 years-old >
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	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 06 Month 19 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2017 Year 06 Month 19 Day
Anticipated trial start date	2017 Year 06 Month 19 Day
Last follow-up date	2017 Year 06 Month 19 Day
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 06 Month 19 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=R000031863