UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study investigating impact of asymptomatic lacunar infarction or cerebral microbleeds on clinical outcome in patients with coronary artery disease
Title of the study (Brief title)	A study of asymptomatic lacunar infarciton or cerebral microbleeds in coronary artery disease patients
Region	Japan

Condition
Condition	coronary artery disease asymptomatic intra-cranial lesions
Classification by specialty	Cardiology Neurology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the impact of asymptomatic lacunar infarction or cerebral microbleeds on clinical outcome in patients with coronary artery disease
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, stroke, unstable angina, and admission due to heart failure)
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	perform head magnetic resonance imaging
Interventions/Control_2	not perform head magnetic resonance imaging
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	coronary artery disease patients
Key exclusion criteria	past history of stroke collagen disease infection severe liver or renal dysfunction malignant disease died during admission
Target sample size	500

Research contact person
Name of lead principal investigator	Seiji Hokimoto
Organization	Graduate School of Medical Sciences, Kumamoto University
Division name	Department of Cardiovascular Medicine
Address	1-1-1, Honjo, Chuo-ku, Kumamoto City
TEL	096-373-5175
Email	shokimot@kumamoto-u.ac.jp

Public contact
Name of contact person	Noriaki Tabata
Organization	Graduate School of Medical Sciences, Kumamoto University
Division name	Department of Cardiovascular Medicine
Address	1-1-1, Honjo, Chuo-ku, Kumamoto City
TEL	096-373-5175
Homepage URL
Email	noriakt@kumamoto-u.ac.jp

Sponsor
Institute	Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University
Institute
Department

Funding Source
Organization	Ministry of Education, Culture, Sports, Science and Technology of Japan
Organization
Division
Category of Funding Organization	Japanese Governmental office
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	2015 Year 11 Month 18 Day

Progress
Recruitment status	Open public recruiting
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	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 11 Month 18 Day
Last modified on	2019 Year 01 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022837