UMIN-CTR Clinical Trial

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

Contact us.