UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040001 |
|---|---|
| Receipt number | 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 12:20:46 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
tnoguchi@ncvc.go.jp
Sponsor or person
Institute
National Cerebral and Cardiovascular Center
Institute
Department
Personal name
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
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
Value
https://center6.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 |
