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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000027101
Receipt No. R000030946
Scientific Title 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.
Date of disclosure of the study information 2017/04/24
Last modified on 2017/04/22

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Basic information
Public title 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.
Acronym Clinical significance of non-contrast T1-weighted plaque imaging for primary prevention of coronary artery disease
Scientific Title 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.
Scientific Title:Acronym 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
1st name
Middle name
Last name Teruo Noguchi
Organization National Cerebral and Cardiovascular Center
Division name Department of cardiovascular disease
Zip code
Address 5-7-1 Fujishirodai, Suita Osaka
TEL 06-6833-5012
Email tnoguchi@ncvc.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Teruo Noguchi
Organization National Cerebral and Cardiovascular Center
Division name Department of cardiovascular disease
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2017 Year 03 Month 31 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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