UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029246 |
|---|---|
| Receipt number | 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 | 2022/08/25 20:58:18 |
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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 intermediate 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 | Yasuhide |
| Middle name | |
| Last name | Asaumi |
Organization
National Cerebral and Cardiovascular Center
Division name
Department of Cardiovascular Medicine
Zip code
564-8565
Address
6-1 Kishibe-shimmachi, Suita, Japan
TEL
06-6170-1070
asaumya@ncvc.go.jp
Public contact
Name of contact person
| 1st name | Yasuhide |
| Middle name | |
| Last name | Yasuhide Asaumi |
Organization
National Cerebral and Cardiovascular Center
Division name
Department of Cardiovascular Medicine
Zip code
564-8565
Address
6-1 Kishibe-shimmachi, Suita, Japan
TEL
06-6170-1070
Homepage URL
asaumiya@ncvc.go.jp
Sponsor or person
Institute
Department of Cardiovascular Medicine, National Cerebral and Cardiovascular Center
Institute
Department
Personal name
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
National Cerebral and Cardiovascular Center
Address
6-1 Kishibe-shimmachi, Suita, Osaka, Japan
Tel
06-6170-1070
rec-office-ac@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
| 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
| 2017 | Year | 03 | Month | 07 | Day |
Anticipated trial start date
| 2017 | Year | 05 | Month | 30 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
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
| 2022 | Year | 08 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033315
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
