UMIN-CTR Clinical Trial

Basic information
Public title	Study for usefulness on cardiac CT strain in evaluation of pathology in cardiac amyloidosis
Acronym	CT strain in cardiac amyloidosis
Scientific Title	Study for usefulness on cardiac CT strain in evaluation of pathology in cardiac amyloidosis
Scientific Title:Acronym	CT strain in cardiac amyloidosis
Region	Japan

Condition
Condition	Cardiac amyloidosis
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluate the diagnostic ability, severity and prognosis of cardiac amyloidosis using cardiac CT strain
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Diagnostic ability and prognosis of 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	Not applicable
Gender	Male and Female
Key inclusion criteria	morethan 20 years old, cardiac CT and echocardiography are performed within 60 days, In case of suspected cardiac amyloidosis, cardiac CT is performed for screening coronary artery disease, evaluation of cardiac thrombosis and TAVI, In case of confirmed cardiac amyloidosis,cardiac CT is performed patients with passed over 2 years after CAG, angina pectoris (even in asymptomatic include a case where there is a ECG changes) or 2 or more coronary risk factors, and eGFR > 45 mL/min/1.73m2 (excluding dialysis patients)
Key exclusion criteria	Patients with a history of hypersensitivity to iodine or iodine contrast media,Patients with asthma and uncontrolled hyperthyroidism, Pregnant and lactating patients,Patients with arrhythmia during cardiac CT imaging,When the investigator determines that it is inappropriate to participate in the research (for example dementia patients)
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Masaki Middle name Last name Kinoshita
Organization	Ehime University Graduate School of Medicine
Division name	Cardiology, Pulmonology, Hypertension and Nephrology
Zip code	791-0295
Address	Shitsukawa, Toon City, Ehime
TEL	089-960-5303
Email	mkino0303@gmail.com

Public contact
Name of contact person	1st name Masaki Middle name Last name Kinoshita
Organization	Ehime University Graduate School of Medicine
Division name	Cardiology, Pulmonology, Hypertension and Nephrology
Zip code	791-0295
Address	Shitsukawa, Toon City, Ehime
TEL	089-960-5303
Homepage URL
Email	mkino0303@gmail.com

Sponsor
Institute	Ehime University Graduate School of Medicine
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Institutional Review Board,Ehime University Hospital
Address	Shitsukawa, Toon, Ehime
Tel	089-960-5172
Email	rinri@m.ehime-u.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	2020 Year 09 Month 01 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	0
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	Terminated
Date of protocol fixation	2020 Year 04 Month 01 Day
Date of IRB	2020 Year 04 Month 28 Day
Anticipated trial start date	2020 Year 06 Month 01 Day
Last follow-up date	2030 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	prospective cohort study

Management information
Registered date	2020 Year 08 Month 25 Day
Last modified on	2022 Year 08 Month 29 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000047284