UMIN-CTR Clinical Trial

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

Chronic myocardial infarction

Classification by specialty

Cardiology

Radiology

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

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

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

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

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

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

Institute

Keio University

Institute

Department

Personal name

Organization

Ziosoft Co.Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

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

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

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）

Date of disclosure of the study information

2017

Year

09

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

85

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

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 related information

This study was registered to jCRT (jRCTs032180317) at 12March2019.

Registered date

2017

Year

07

Month

06

Day

Last modified on

2022

Year

07

Month

13

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032166