UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of screening for primary prevention of mortality and cardiovascular events using non-contrast T1-weighted magnetic resonance plaque imaging in high-risk patients estimated by risk factor categories for a Japanese urban population.
Title of the study (Brief title)	Clinical significance of non-contrast T1-weighted plaque imaging for primary prevention of coronary artery disease
Region	Japan

Condition
Condition	Patients with primary prevention for coronary disease:hypertension, diabetes mellitus, dyslipidemia, stroke, aortic disease, atherosclerotic obliterans, or chronic kidney disease.
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to determine whether coronary high-intensity plaque (HIP) visualized by non-contrast T1-weighted imaging (T1WI) can predict mortality and future coronary events for primary prevention.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The primary outcome is a composite of all-cause mortality, carddiac mortality, stroke, nonfatal myocardial infarction, or ischemia proven unstable angina, stable effort angina, and silent myocardial ischemia, requiring coronary intervention.
Key secondary outcomes	Cardiac death. Composite of cardiovascular event of cardiac mortality, nonfatal myocardial infarction, ischemia proven unstable angina, stable effort angina, andsilent myocardial ischemia requiring coronary intervention. Prevalence of coronary HIP. Risk factor for coronary HIP. Analysis for cost-effectiveness.

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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1)Patients with high cardiac risk estimated by risk factor categories for a Japanese urban population Suita score(greater than 51 points). 2) Diabetic patients (more than 49 years old male or more than 54 years old female). 3) Patients with suspected of coronary artery disease who met criteria for intermediated coronary stenosis detected by CT angiography or invasive coronary angiography
Key exclusion criteria	1) Internal metal 2) History of coronary artery disease (history of antianginal medication, CABG, or PCI) 3) Patients with severe stenosis detected by CTA. 4)refusal of informed consent
Target sample size	660

Research contact person
Name of lead principal investigator	Teruo Noguchi
Organization	National Cerebral and Cardiovascular Center
Division name	Department of cardiovascular disease
Address	5-7-1 Fujishirodai, Suita Osaka
TEL	06-6833-5012
Email	tnoguchi@ncvc.go.jp

Public contact
Name of contact person	Teruo Noguchi
Organization	National Cerebral and Cardiovascular Center
Division name	Department of cardiovascular disease
Address	5-7-1 Fujishirodai, Suita Osaka
TEL	06-6833-5012
Homepage URL
Email	tnoguchi@ncvc.go.jp

Sponsor
Institute	National Cerebral and Cardiovascular Center
Institute
Department

Funding Source
Organization	AMED
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	2017 Year 04 Month 24 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 03 Month 31 Day
Anticipated trial start date	2017 Year 04 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	DESIGN, SETTING, AND PARTICIPANTS: A multicenter prospective observational study in which 660 patients with high cardiac risk estimated by risk factor categories for a Japanese urban population Suita score are recruited from 6 institutions. After CMR data are obtained, study patients are divided into 3 groups according to the PMR cutoff value of 1.4 or 1.1 as follows: PMR >1.4, PMR 1.1 to 1.4, and PMR <1.1 and follow at least 3 to 6 years until the occurrence of 1 of the following coronary events. MAIN OUTCOMES AND MEASURES: The primary outcome is a composite of all-cause mortality, cardiac mortality, stroke, nonfatal MI, or ischemia proven unstable angina, stable effort angina, and silent myocardial ischemia, requiring coronary intervention. ANTICIPATED RESULTS: Among the 3 groups based on PMR cutoff, the primary outcome event rate is highest in the group with PMR >1.4 and lowest in the group with PMR <1.1.

Management information
Registered date	2017 Year 04 Month 22 Day
Last modified on	2017 Year 04 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030946