UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024277 |
|---|---|
| Receipt number | R000027955 |
| Scientific Title | Feasibility of cardiac computed tomography 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 | 2024/10/10 09:25:43 |
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Basic information
Public title
Feasibility of cardiac computed tomography for assessment of left ventricular hypertrophy
Acronym
Feasibility of cardiac computed tomography for assessment of left ventricular hypertrophy
Scientific Title
Feasibility of cardiac computed tomography for assessment of severity and prognosis in patients with left ventricular hypertrophy
Scientific Title:Acronym
Feasibility of cardiac computed tomography 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 cardiac computed tomography (CT) analysis such as CT strain delayed enhancement CT for the assessment of 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 cardiac CT (CT strain, delayed enhancement CT): 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 enhanced CT)
Feasibility of another parameters such as strain rate and minimum principal strain
Feasibility of LV CT-strain analysis for systolic and diastolic dysfunction
Differentiation of hypertrophic heart using CT strain and strain curve
Comparison of delayed enhanced CT and LGE MRI
Differentiation of cardiac hypertrophy severity using delayed enhanced CT or CT strain
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
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
200
Research contact person
Name of lead principal investigator
| 1st name | Yuki |
| Middle name | |
| Last name | Tanabe |
Organization
Ehime University Hospital School of Medicine
Division name
Radiology
Zip code
791-0295
Address
Shitsukawa, Toon, Ehime, Japan
TEL
+81-89-960-5371
yuki.tanabe.0225@gmail.com
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Tanabe |
Organization
Ehime University Hospital School of Medicine
Division name
Radiology
Zip code
7910295
Address
Shitsukawa, Toon, Ehime, Japan
TEL
+81-89-960-5371
Homepage URL
yuki.tanabe.0225@gmail.com
Sponsor or person
Institute
Ehime University Hospital School of Medicine
Institute
Department
Personal name
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
Institutional Review Board,Ehime University Hospital
Address
Shitsukawa, Toon, Ehime
Tel
089-960-5172
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
| 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
Terminated
Date of protocol fixation
| 2016 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 10 | Month | 04 | Day |
Anticipated trial start date
| 2016 | Year | 10 | Month | 04 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
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
| 2024 | Year | 10 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027955
