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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000028097
Receipt No. R000032166
Scientific Title CT strain analysis: Study for evaluating detectability of abnormal wall motion comparing with MRI tagging study in the patients with chronic myocardial infarction
Date of disclosure of the study information 2017/09/01
Last modified on 2019/06/03

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Basic information
Public title CT strain analysis: Study for evaluating detectability of abnormal wall motion comparing with MRI tagging study in the patients with chronic myocardial infarction
Acronym Study for evaluating detectability of CT strain analysis comparing MRI tagging study
Scientific Title CT strain analysis: Study for evaluating detectability of abnormal wall motion comparing with MRI tagging study in the patients with chronic myocardial infarction
Scientific Title:Acronym Study for evaluating detectability of CT strain analysis comparing MRI tagging study
Region
Japan

Condition
Condition Chronic myocardial infarction
Classification by specialty
Cardiology Radiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the detectability of CT strain for abnormal wall motion of the left ventricle in patients with chronic myocardial infarction, in comparison with MR tagging.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes To evaluate the consistency between CT strain and MR late gadolinium enhancement for detecting abnormal myocardium.
Key secondary outcomes The relationship between global strain in CT and MR
The relationship between segmental strain on CT and MR
Intra-observer agreement in segmental strain
Inter-observer agreement in segmental strain

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Other
Interventions/Control_1 Contrast enhanced cardiac MRI including cine, tagging, late Gd enhancement
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
80 years-old >
Gender Male and Female
Key inclusion criteria 1.A person who has contraindication to neither iodine nor Gd contrast material.
2.A person who has not metallic devices which is unsafe to MRI nor who is not claustrophobia. A person who has not MRI-conditional devices including pacemaker or ICD.
3.A person who can understand the explanations about this study through written informed consent, and who can cooperate to the study.
4.A person whose age is greater than 20 y/o and less than 80 y/o.
Key exclusion criteria 1. A person who had a contraindication for using iodine or/and Gd contrast material.
a.with a history of allergy to these agents
b.with insufficiency of renal function (eGFR is less than 30)
c.with asthma
2. A person who has a contraindication for MRI scanning/
a.claustrophobia
b.with non-conditional metallic device
c.with MRI-conditional devices (pacemaker or ICD)
3. A person who cannot be control his/her breathing during the examination.
4. A person who dose not agree with the written informed consent.

Target sample size 125

Research contact person
Name of lead principal investigator
1st name Masahiro
Middle name
Last name Jinzaki
Organization Keio University School of Medicine
Division name Department of Radiology
Zip code 160-8582
Address Shinanomachi 35, Shinjyuku-ku, Tokyo, Japan
TEL 03-3353-1211
Email jinzaki@rad.med.keio.ac.jp

Public contact
Name of contact person
1st name Shigeo
Middle name
Last name Okuda
Organization Keio University School of Medicine
Division name Department of Radiology
Zip code 160-8582
Address Shinanomachi 35, Shinjyuku-ku, Tokyo, Japan
TEL 03-3353-1211
Homepage URL
Email okuda@rad.med.keio.ac.jp

Sponsor
Institute Keio University
Institute
Department

Funding Source
Organization Ziosoft Co.Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Certified Review Board of Keio
Address Shinanomachi, Shinjuku-ku, Tokyo
Tel 03-5363-3503
Email med-nintei-jimu@adst.keio.ac.jp

Secondary IDs
Secondary IDs YES
Study ID_1 jRCTs032180317
Org. issuing International ID_1 Japan Registry of Clinical Trials
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 愛媛大学病院(愛媛県)、熊本大学病院(熊本県)、慶應義塾大学病院(東京都)、東京女子医科大学病院(東京都)、東北大学病院(宮城県)

Other administrative information
Date of disclosure of the study information
2017 Year 09 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
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
2018 Year 06 Month 01 Day
Date of IRB
2017 Year 07 Month 22 Day
Anticipated trial start date
2018 Year 06 Month 08 Day
Last follow-up date
2022 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 07 Month 06 Day
Last modified on
2019 Year 06 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032166

Research Plan
Registered date File name
2019/06/03 4_研究計画書_ver2.2_20190306.docx

Research case data specifications
Registered date File name
2019/06/03 51_SUMMIT_CRF_ver3.xlsx

Research case data
Registered date File name
2019/06/13 【新】51_SUMMIT_CRF_ver3.2.xlsx


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