UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028097 |
|---|---|
| Receipt number | 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 | 2026/01/12 19:29:53 |
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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
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
okuda@rad.med.keio.ac.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
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
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
none
Publication of results
Unpublished
Result
URL related to results and publications
none
Number of participants that the trial has enrolled
79
Results
We evaluated the concordance between areas of reduced maximum principal strain (MPS) calculated from coronary CTA and areas of myocardial infarction detected by LGE on cardiac MRI. The sensitivity and specificity of MPS map for detecting LGE were 81% and 48%, respectively. The PPV, NPV and accurate were 36%, 89%, and 59%, respectively. The high NPV suggests this method may be useful for detecting normal myocardial wall motion.
Results date posted
| 2026 | Year | 01 | Month | 12 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients with chronic coronary artery disease undergoing follow-up were enrolled in this study.
Participant flow
Participants scheduled to undergo CCTA and cardiac MRI were enrolled in the study after receiving an explanation of the research and providing informed consent.
Adverse events
None
Outcome measures
Segments with reduced myocardial contractility were detected from the MPS map obtained from CCTA, and their consistency was evaluated with segments exhibiting contrast enhancement exceeding half the wall thickness on cardiac MRI-LGE.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
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
This study was registered to jCRT (jRCTs032180317) at 12March2019.
Management information
Registered date
| 2017 | Year | 07 | Month | 06 | Day |
Last modified on
| 2026 | Year | 01 | Month | 12 | Day |
Link to view the page
Value
https://center6.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 |
| 2020/03/15 | 【SUMMIT_CRF】_ver3.2_KU_20200315.xlsx |
Single case data URL
Value
https://center6.umin.ac.jp/ice/32166
