UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053389 |
|---|---|
| Receipt number | R000060884 |
| Scientific Title | Development of a new diagnostic method for cardiac amyloidosis by delayed contrast-enhanced quantification of myocardium using single-energy CT. |
| Date of disclosure of the study information | 2024/01/18 |
| Last modified on | 2024/07/19 20:38:34 |
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Basic information
Public title
Development of a diagnostic method for cardiac amyloidosis by delayed contrast imaging of myocardium using CT.
Acronym
Development of a diagnostic method for cardiac amyloidosis using contrast imaging of myocardium with CT.
Scientific Title
Development of a new diagnostic method for cardiac amyloidosis by delayed contrast-enhanced quantification of myocardium using single-energy CT.
Scientific Title:Acronym
Development of a diagnostic method for cardiac amyloidosis by delayed contrast imaging using single-energy CT.
Region
| Japan |
Condition
Condition
cardiac amyloidosis
Classification by specialty
| Cardiology | Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop a diagnostic method for cardiac amyloidosis similar to dual-energy CT by acquiring two images with single-energy CT.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of a diagnostic method by delayed contrast-enhanced images using single energy CT in patients with cardiac amyloidosis.
Key secondary outcomes
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Patients for whom a preoperative contrast CT scan for transcatheter aortic valve implantation will be performed, who can use the necessary amount of contrast media and can hold their breath for 25 to 30 seconds.
(2) Patients who are at least 20 years old and less than 90 years old at the time of obtaining consent.
(3) Patients who have been diagnosed with chronic myocardial infarction based on the diagnostic criteria of the Guidelines for the Diagnosis of Chronic Coronary Artery Disease and have imaging findings on delayed contrast-enhanced MRI images or cardiac nuclear medicine examinations (SPECT, PET), or who are suspected to have cardiac amyloidosis based on echocardiographic or electrocardiographic findings, or who are eligible for additional examinations in the future if imaging is necessary (iv) Patients who have agreed to participate in this study.
(4) Patients who have agreed to participate in this study.
Key exclusion criteria
(1) Patients with a heart rate of 80 or more or with arrhythmia
(2) Patients with a cardiac pacemaker
(iii) Patients who are 90 years of age or older and are considered to have difficulty holding their breath for 25-30 seconds
(iv) Patients with psychiatric disorders or psychiatric symptoms that make it difficult for them to participate in the study.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Hirofumi |
| Middle name | |
| Last name | Sekino |
Organization
Fukushima Medical University
Division name
Department of Radiology and Nuclear medicine
Zip code
9601295
Address
Hikarigaoka 1, Fukushima-Shi, Fukushima, Japan
TEL
0245471111
sekino@fmu.ac.jp
Public contact
Name of contact person
| 1st name | Hirofumi |
| Middle name | |
| Last name | Sekino |
Organization
Fukushima Medical University
Division name
Department of Radiology and Nuclear medicine
Zip code
960-1295
Address
Hikarigaoka 1, Fukushima-Shi, Fukushima, Japan
TEL
0245471111
Homepage URL
sekino@fmu.ac.jp
Sponsor or person
Institute
Fukushima Medical University
Institute
Department
Personal name
Funding Source
Organization
JSPS
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fukushima Medical University
Address
Hikarigaoka 1, Fukushima-Shi, Fukushima, Japan
Tel
024547111
fmu@esct.bvits.com
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
| 2024 | Year | 01 | Month | 18 | 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
| 2023 | Year | 12 | Month | 20 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 20 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 18 | Day |
Last follow-up date
| 2028 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2024 | Year | 01 | Month | 18 | Day |
Last modified on
| 2024 | Year | 07 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060884
