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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000040001
Receipt No. R000045598
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 2020/04/01
Last modified on 2020/03/31

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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 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 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 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.
Region
Japan

Condition
Condition Subjects with high cardiac risk estimated by risk factor categories for a Japanese urban population Suita score
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to determine whether coronary HIP visualized by non-contrast 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 Composite of all-cause mortality, cardiac mortality, stroke, nonfatal MI, ischemia proven unstable angina, or stable effort angina and silent myocardial ischemia requiring coronary intervention.
Key secondary outcomes 1. Cardiac mortality
2. Composite of cardiac mortality, nonfatal MI, ischemia proven unstable angina,or stable effort angina and silent myocardial ischemia requiring coronary intervention.
3. Prevalence of HIP at Suita score cut-off value of >51.
4. Cut-off value of Suita score for estimated PMR >1.4.
5. Cost-effective analysis for MR plaque imaging

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
90 years-old >=
Gender Male and Female
Key inclusion criteria Subjects with primary prevention for coronary artery disease who have Japanese urban population Suita score >51, male subjects older than 55 years with diabetes mellitus, or female subjects older than 65 years with diabetes mellitus
Key exclusion criteria 1. Patients with coronary artery disease
2. Subjects without consent
3. MRI contraindicated subjects
Target sample size 660

Research contact person
Name of lead principal investigator
1st name Teruo
Middle name
Last name Noguchi
Organization National Cerebral and Cardiovascular Center
Division name Department of Cardiovascular Medicine
Zip code 564-8565
Address 6-1 Kishibe-Shimmachi, Suita, Osaka JAPAN
TEL 06-6170-1070
Email tnoguchi@ncvc.go.jp

Public contact
Name of contact person
1st name Teruo
Middle name
Last name Noguchi
Organization National Cerebral and Cardiovascular Center
Division name Department of Cardiovascular Medicine
Zip code 564-8565
Address 6-1 Kishibe-Shimmachi, Suita, Osaka JAPAN
TEL 06-6170-1070
Homepage URL
Email tnoguchi@ncvc.go.jp

Sponsor
Institute National Cerebral and Cardiovascular Center
Institute
Department

Funding Source
Organization Japan Agency for Medical Reseach and Development
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 National Cerebral and Cardiovascular Center, Research Ethics Review Committee
Address 6-1 Kishibe-Shimmachi, Suita, Osaka JAPAN
Tel 06-6170-1070
Email rec-officeac@ncvc.go.jp

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
2020 Year 04 Month 01 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 859
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 No longer recruiting
Date of protocol fixation
2017 Year 04 Month 02 Day
Date of IRB
2017 Year 04 Month 02 Day
Anticipated trial start date
2017 Year 04 Month 03 Day
Last follow-up date
2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information OBJECTIVE: The aim of this study is to determine whether coronary HIP visualized by non-contrast T1WI can predict mortality and future coronary events for primary prevention.
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.
CONCLUSIONS AND RELEVANCE: Coronary HIP is significantly associated with coronary events and may thus represent a novel predictive factor for primary prevention. Among high cardiac risk patients at primary prevention, use of non-contrast T1WI to screen for coronary HIP may reduce the composite cardiovascular events.


Management information
Registered date
2020 Year 03 Month 31 Day
Last modified on
2020 Year 03 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045598

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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