UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056610 |
|---|---|
| Receipt number | R000064613 |
| Scientific Title | Clinical utility of noninvasive imaging in patients with suspected transthyretin amyloid cardiomyopathy: a multicenter registry |
| Date of disclosure of the study information | 2024/12/31 |
| Last modified on | 2024/12/31 11:19:00 |
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Basic information
Public title
Clinical utility of noninvasive imaging in patients with suspected transthyretin amyloid cardiomyopathy: a multicenter registry
Acronym
Clinical utility of noninvasive imaging in patients with suspected ATTR-CM: a multicenter registry
Scientific Title
Clinical utility of noninvasive imaging in patients with suspected transthyretin amyloid cardiomyopathy: a multicenter registry
Scientific Title:Acronym
Clinical utility of noninvasive imaging in patients with suspected ATTR-CM: a multicenter registry
Region
| Japan |
Condition
Condition
Transthyretin amyloid cardiomyopathy (ATTR-CM)
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study focused on patients who underwent 99mTc-pyrophosphate scintigraphy for suspected ATTR-CM in Japan 1) to examine differences in baseline characteristics, laboratory findings, the diagnosis rate of ATTR-CM or other cardiomyopathies, and the prognosis between patients with and without positive 99mTc-pyrophosphate scintigraphy, 2) to understand the current clinical practice for the evaluation of ATTR-CM using 99mTc-pyrophosphate scintigraphy in Japan, and 3) to assess the prognostic value of 99mTc-pyrophosphate scintigraphy in patients with suspected ATTR-CM.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Differences in the degrees of 99mTc-pyrophosphate uptakes and the diagnosis rate of ATTR-CM among the different categories of patients with suspected ATTR-CM (i.e., age, sex, and LVEF [<40%, 40-50%, and >50%]).
Key secondary outcomes
1) To assess the association between the degrees of 99mTc-pyrophosphate uptakes, all-cause death, and clinical events.
2) To assess the clinical validity of Kumamoto Criteria and Mayo Simple Score for the prediction of 99mTc-pyrophosphate uptakes and the diagnosis of ATTR-CM.
3) To develop novel clinical scores for the prediction of 99mTc-pyrophosphate uptakes and the diagnosis of ATTR-CM.
4) To assess the association between the degrees of 99mTc-pyrophosphate uptakes and the diagnosis rate of non-ATTR-CM cardiomyopathies.
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
| 1 | days-old | <= |
Age-upper limit
| 120 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with suspected ATTR-CM who underwent 99mTc-pyrophosphate scintigraphy between January 1, 2010, and September 30, 2024 (regardless of age)
Key exclusion criteria
1) Cases in which the image evaluation using 99mTc-pyrophosphate scintigraphy is difficult.
2) Patients who are judged as ineligible for this study by the research director.
Target sample size
5000
Research contact person
Name of lead principal investigator
| 1st name | Yuya |
| Middle name | |
| Last name | Matsue |
Organization
Juntendo University Hospital
Division name
Department of Cardiovascular Biology and Medicine
Zip code
113-8431
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo
TEL
03-3813-3111
yuya8950@gmail.com
Public contact
Name of contact person
| 1st name | Tadao |
| Middle name | |
| Last name | Aikawa |
Organization
Juntendo University Hospital
Division name
Department of Cardiovascular Biology and Medicine
Zip code
113-8431
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo
TEL
03-3813-3111
Homepage URL
tadao.aikawa@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
Kanzawa Medical Research Foundation
Daiwa Securities Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee, Faculty of Medicine, Juntendo University
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo
Tel
03-3814-5672
hongo-rinri@juntendo.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
順天堂大学医学部附属順天堂医院（東京都）
慶応義塾大学病院（東京都）
九州大学病院（福岡県）
神戸大学医学部附属病院（兵庫県）
国立循環器病研究センター（大阪府）
高知大学医学部附属病院（高知県）
佐賀大学医学部附属病院（佐賀県）
広島大学病院（広島県）
順天堂大学医学部附属浦安病院（千葉県）
北海道循環器病院（北海道）
札幌医科大学附属病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 12 | Month | 31 | 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
| 2024 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 05 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Clinical follow-up will be performed by reviewing the patients' medical records.
Management information
Registered date
| 2024 | Year | 12 | Month | 31 | Day |
Last modified on
| 2024 | Year | 12 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064613
