UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022839 |
|---|---|
| Receipt number | R000026322 |
| Scientific Title | Development of assessment technique for regional wall motion of left ventricle using multi-detector computed tomography |
| Date of disclosure of the study information | 2016/06/22 |
| Last modified on | 2022/12/27 17:24:59 |
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Basic information
Public title
Development of assessment technique for regional wall motion of left ventricle using multi-detector computed tomography
Acronym
Development of assessment technique for regional wall motion of left ventricle using MDCT
Scientific Title
Development of assessment technique for regional wall motion of left ventricle using multi-detector computed tomography
Scientific Title:Acronym
Development of assessment technique for regional wall motion of left ventricle using MDCT
Region
| Japan |
Condition
Condition
ischemic heart disease, cardiomyopathy, heart failure, etc
Classification by specialty
| Cardiology | Radiology | Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop the assessment technique for regional wall motion of the left ventricle using MDCT
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To develop a technique for quantifying and visualizing regional wall motion of the left ventricle using multi-detector computed tomography
Key secondary outcomes
To validate the outcomes comparing with other modalities (e.g. echocardiography, cardiac magnetic resonance imaging, cardiac scintigraphy)
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients scheduled to undergo coronary CT angiogram for their treatment
Key exclusion criteria
No informed consent
Contraindication for iodine contrast agent
Pregnancy
Not sinus rhythm or sinus rhythm with heart rate >65 bpm with contraindication for Beta blocker
Not to be able to hold the breath =>10 seconds
To be judged ineligible by the investigators
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Matsui |
| Middle name | |
| Last name | Yoshiro |
Organization
Hokkaido University Graduate School of Medicine
Division name
Department of Cardiovascular and Thoracic Surgery
Zip code
060-8638
Address
West7, North15, Kita-ku, Sapporo 060-8638, Japan
TEL
011-706-6042
ymatsui@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Wakasa |
| Middle name | |
| Last name | Satoru |
Organization
Hokkaido University Graduate School of Medicine
Division name
Department of Cardiovascular and Thoracic Surgery
Zip code
0608648
Address
West7, North15, Kita-ku, Sapporo 060-8638, Japan
TEL
011-706-6042
Homepage URL
wakasa@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Graduate School of Medicine Department of Cardiovascular and Thoracic Surgery
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hokkaido University Hospital Clinical Research and Medical Innovation Center
Address
Kita 14, Nishi 5, Kita-ku, Sapporo, Hokkaido
Tel
+81-11-706-7061
crjimu@huhp.hokudai.ac.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
| 2016 | Year | 06 | Month | 22 | Day |
Related information
URL releasing protocol
https://www.huhp.hokudai.ac.jp/date/rinsho-johokokai/approval/2016-7/
Publication of results
Published
Result
URL related to results and publications
https://ui.adsabs.harvard.edu/abs/2019PMB....64e5009K/abstract
Number of participants that the trial has enrolled
10
Results
The result suggests that proposed endocardial deformation analysis using CT can be conducted on site and in time for the acute
setting, and may be useful for the diagnosis of cardiac dysfunction or myocardial ischemia.
Results date posted
| 2022 | Year | 12 | Month | 27 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
From July 2016 to February 2017, cardiac CT data were collected from ten consecutive subjects (41-80 years old) who underwent a coronay CT examination for clinical reasons at Hokkaido University Hospital.
Participant flow
Retrospective analysis of patient data undergoing coronary CT
Adverse events
None
Outcome measures
Our study of 65 endocardial segments in ten subjects showed that global endocardial deformation has a positive relationship with the stroke volume index (r = 0.896 and 0.829 in E and S, respectively) and ejection fraction (r = 0.804 and 0.835). A positive relationship between segmental E and S (r = 0.845), a higher value of E in ischemic segments (p = 0.021) that are determined by fractional flow reserve estimated from coronary CT data, and a higher value of S in the left circumflex artery territory (p < 0.05) were also observed. The required radiation dose was 5.0 +- 0.7 mSv and the computation time was 7.2 +- 1.1 min.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 06 | Month | 03 | Day |
Date of IRB
| 2016 | Year | 05 | Month | 16 | Day |
Anticipated trial start date
| 2016 | Year | 06 | Month | 03 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
None
Management information
Registered date
| 2016 | Year | 06 | Month | 22 | Day |
Last modified on
| 2022 | Year | 12 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026322
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