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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000029246
Receipt No. R000033315
Scientific Title Evaluation of coronary atherosclerosis on T1WI for preventing future events registry (secondary prevention)
Date of disclosure of the study information 2017/09/22
Last modified on 2017/09/23

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Basic information
Public title Evaluation of coronary atherosclerosis on T1WI for preventing future events registry (secondary prevention)
Acronym T1WI CAD 2nd prevention registry
Scientific Title Evaluation of coronary atherosclerosis on T1WI for preventing future events registry (secondary prevention)
Scientific Title:Acronym T1WI CAD 2nd prevention registry
Region
Japan

Condition
Condition Ischemic heart disease
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the relationship between clinical outcomes following several interventions (medications, percutaneous coronary interventions, or coronary artery bypass grafting) and coronary plaque morphology detected on non-contrast T1 weighted magnetic resonance (T1WI).
Basic objectives2 Others
Basic objectives -Others (A) To examine the clinical outcomes following plaque evaluation by T1WI in patients with coronary artery disease.
(B) To examine the relationships between coronary plaque morphology by T1WI and the occurrence of myocardial ischemia.
(C) To examine the predictive values of plaque evaluation by T1WI during percutaneous coronary intervention.
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Composite of major adverse event (cardiac death, myocardial infarction (3rd universal definition: type1), new ischemia driven coronary revascularization)
Key secondary outcomes All-cause death
Cardiac death
Cardiovascular death
Myocardial infarction/unstable angina
New ischemia driven coronary revascularization
Occurrence of periprocedural myocardial injury during percutaneous coronary intervention (PCI) (3rd Universal definition type 4).
Slow flow phenomenon during PCI.

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
85 years-old >=
Gender Male and Female
Key inclusion criteria Patients with (A) stable coronary artery disease (B) unstable angina (C) acute myocardial infarction (Type 1 by 3rd universal definition) without indication of primary PCI, who has significant stenosis (more than and equal 50% stenosis) at proximal segment of each coronary vessels (segments #1, #2, #3, #5, #6, #7, #11, or #13) detected on coronary computed tomography angiography (CCTA) or invasive coronary angiography (CAG) and undergo coronary magnetic resonance for plaque evaluation by T1WI within 3 months before/after anatomical evaluation by CCTA, CAG evaluation or both.
Key exclusion criteria Patients with MRI contraindication
Patients with chronic kidney disease (stage 4 and 5) or with hemodialysis
Patients with pacemaker, implantable cardiodefibrillatior
Patients with heart rhythm irregularity (Atrial fibrillation etc)
Patients with claustrophobia
Patients judged as inappropriate by each researcher
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasuhide Asaumi
Organization National Cerebral and Cardiovascular Center
Division name Department of Cardiovascular Medicine
Zip code
Address 5-7-1 Fujishiro-dai, Suita, Japan
TEL 06-6833-5012
Email asaumi.yasuhide.hp@ncvc.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yasuhide Asaumi
Organization National Cerebral and Cardiovascular Center
Division name Department of Cardiovascular Medicine
Zip code
Address 5-7-1 Fujishiro-dai, Suita, Japan
TEL 06-6833-5012
Homepage URL
Email asaumi.yasuhide.hp@ncvc.go.jp

Sponsor
Institute Department of Cardiovascular Medicine, National Cerebral and Cardiovascular Center
Institute
Department

Funding Source
Organization Japan agency for medical research 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
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 09 Month 22 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 Enrolling by invitation
Date of protocol fixation
2017 Year 05 Month 30 Day
Date of IRB
Anticipated trial start date
2017 Year 05 Month 30 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information (A)

Management information
Registered date
2017 Year 09 Month 22 Day
Last modified on
2017 Year 09 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033315

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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