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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | |||
Condition | cardiomyopathy | ||
Classification by specialty |
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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 | |
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Eligibility | ||||
Age-lower limit |
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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 |
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Target sample size | 100 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Ehime University Hospital School of Medicine | ||||||
Division name | Radiology | ||||||
Zip code | |||||||
Address | Shitsukawa, Toon, Ehime, Japan | ||||||
TEL | +81-89-960-5371 | ||||||
yuki.tanabe.0225@gmail.com |
Public contact | |||||||
Name of contact person |
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Organization | Ehime University Hospital School of Medicine | ||||||
Division name | Radiology | ||||||
Zip code | |||||||
Address | Shitsukawa, Toon, Ehime, Japan | ||||||
TEL | +81-89-960-5371 | ||||||
Homepage URL | |||||||
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 |
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IRB Contact (For public release) | |
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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 |
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Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
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Results | |
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Results Delayed | |
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Baseline Characteristics | |
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IPD sharing Plan description |
Progress | |||||||
Recruitment status | Open public recruiting | ||||||
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Other | |
Other related information | Prospective study |
Management information | |||||||
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Last modified on |
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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 |