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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000024277
Receipt No. R000027955
Scientific Title Feasibility of computed tomography strain for assessment of severity and prognosis in patients with left ventricular hypertrophy
Date of disclosure of the study information 2016/10/04
Last modified on 2016/10/04

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Basic information
Public title Feasibility of computed tomography strain for assessment of severity and prognosis in patients with left ventricular hypertrophy
Acronym Feasibility of computed tomography strain for assessment of left ventricular hypertrophy
Scientific Title Feasibility of computed tomography strain for assessment of severity and prognosis in patients with left ventricular hypertrophy
Scientific Title:Acronym Feasibility of computed tomography strain for assessment of left ventricular hypertrophy
Region
Japan

Condition
Condition cardiomyopathy
Classification by specialty
Cardiology Radiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the feasibility of computed tomography (CT) strain analysis for the assessment of severity and prognosis in patients with left ventricular (LV) hypertrophy
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Prognostic value of LV CT-strain findings: total mortality, cardiac death, acute myocardial infarction, admission with cardiac decompensation
Key secondary outcomes Comparison LV CT-strain with magnetic resonance imaging and echocardiogram (strain, morphological features, cardiac function, fibrosis (delayed enhancement))
Feasibility of another parameters such as strain rate and minimum principal strain
Feasibility of LV CT-strain analysis for systolic and diastolic dysfunction

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
85 years-old >=
Gender Male and Female
Key inclusion criteria Patients with known/suspected LV hypertrophy (Hypertensive Heart Disease, Hypertrophic Cardiomyopathy, Amyloidosis)
Key exclusion criteria Acute coronary syndrome, unstable angina, malignant arrhythmia, severe left ventricular dysfunction, aortic valve stenosis
Old myocardial infarction
Atrial fibrillation
Greater than first degree atrioventricular block, and sick sinus syndrome
Percutaneous coronary intervention within 6 months
Coronary artery bypass grafting
Patient with pacemaker and implantable cardioverter defibrillator
Patient with claustrophobia
30% and more than coronary artery stenosis on coronary CT angiography (CTA)
Known allergic reaction to contrast media
Known history of hyperthyroidism and bronchial asthma
Chronic kidney disease
Pregnancy
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuki Tanabe
Organization Ehime University Hospital School of Medicine
Division name Radiology
Zip code
Address Shitsukawa, Toon, Ehime, Japan
TEL +81-89-960-5371
Email yuki.tanabe.0225@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Yuki Tanabe
Organization Ehime University Hospital School of Medicine
Division name Radiology
Zip code
Address Shitsukawa, Toon, Ehime, Japan
TEL +81-89-960-5371
Homepage URL
Email yuki.tanabe.0225@gmail.com

Sponsor
Institute Ehime University Hospital School of Medicine
Institute
Department

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
Address
Tel
Email

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 10 Month 04 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 Open public recruiting
Date of protocol fixation
2016 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 10 Month 04 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Prospective study

Management information
Registered date
2016 Year 10 Month 04 Day
Last modified on
2016 Year 10 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027955

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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