UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052014 |
|---|---|
| Receipt number | R000059371 |
| Scientific Title | Research on the Optimization of Myocardial Delayed Contrast-Enhanced Images Using Dual-Energy CT and Evaluation of Myocardial Tissue Utilizing These Images |
| Date of disclosure of the study information | 2023/08/28 |
| Last modified on | 2023/08/26 17:39:36 |
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Basic information
Public title
Research Aimed at Optimizing State-of-the-Art CT Images for Myocardial Evaluation
Acronym
Myocardial Evaluation Using State-of-the-Art CT
Scientific Title
Research on the Optimization of Myocardial Delayed Contrast-Enhanced Images Using Dual-Energy CT and Evaluation of Myocardial Tissue Utilizing These Images
Scientific Title:Acronym
Myocardial Evaluation Using DECT
Region
| Japan |
Condition
Condition
chronic myocardial infarction
Classification by specialty
| Cardiology | Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Assessment of the utility of late iodine enhancement (LIE) through the utilization of images acquired via image-based dual-energy (DE) analysis, employing a pair of single-energy volumetric CT scans at tube voltages of 135 and 80 kV.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Examine the potential for discerning abnormal regions identified in Late Gadolinium Enhancement (LGE), Single Photon Emission Computed Tomography (SPECT), and Positron Emission Tomography (PET) through the utilization of the iodine map and virtual kilovolt image.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Supplement the conventional contrast-enhanced CT (135 kV) with an additional instance of 80 kV CT scan. The radiation dosage incurred by the supplementary CT scan is anticipated to exhibit an approximate elevation of 1.3 mSv.
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
| 16 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Individuals who have received a diagnosis of chronic myocardial infarction in accordance with the diagnostic parameters delineated within the guidelines for chronic coronary artery disease diagnosis,
and who present imaging manifestations on myocardial delayed contrast-enhanced magnetic resonance imaging (MRI) scans or cardiac nuclear medicine evaluations (SPECT, PET).
Key exclusion criteria
Individuals exhibiting a heart rate surpassing 80 beats per minute or experiencing arrhythmia, alongside those who are recipients of cardiac pacemaker devices.
Target sample size
4
Research contact person
Name of lead principal investigator
| 1st name | Ito |
| Middle name | |
| Last name | hiroshi |
Organization
Fukushima Medical University
Division name
Department of Radiology and Nuclear Medicine
Zip code
9601295
Address
1 Hikariga-oka, Fukushima City
TEL
0245471111
h-ito@fmu.ac.jp
Public contact
Name of contact person
| 1st name | Fukushima |
| Middle name | |
| Last name | Kenji |
Organization
Fukushima Medical University
Division name
Department of Radiology and Nuclear Medicine
Zip code
9601295
Address
1 Hikariga-oka, Fukushima City
TEL
0245471111
Homepage URL
kfukush4@fmu.ac.jp
Sponsor or person
Institute
Fukushima Medical University
Institute
Department
Personal name
Ito Hiroshi
Funding Source
Organization
Fukushima Medical University, Department of Radiology and Nuclear Medicine
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
Fukushima Medical University Certified Review Board
Address
1 Hikariga-oka, Fukushima City
Tel
0245471825
rs@fmu.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
公立大学法人福島県立医科大学附属病院（福島県）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 08 | Month | 28 | 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
4
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
Completed
Date of protocol fixation
| 2022 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 30 | Day |
Anticipated trial start date
| 2023 | Year | 02 | Month | 20 | Day |
Last follow-up date
| 2033 | Year | 01 | 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
| 2023 | Year | 08 | Month | 26 | Day |
Last modified on
| 2023 | Year | 08 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059371
