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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 | UMIN000024276 |
Receipt No. | R000027953 |
Scientific Title | Feasibility of late iodine enhancement computed tomography (LIE-CT) for assessment of severity and prognosis of patients with myocardial infarction |
Date of disclosure of the study information | 2016/10/04 |
Last modified on | 2016/10/04 |
Basic information | ||
Public title | Feasibility of late iodine enhancement computed tomography (LIE-CT) for assessment of severity and prognosis of patients with myocardial infarction | |
Acronym | Feasibility of LIE-CT for detecting MI | |
Scientific Title | Feasibility of late iodine enhancement computed tomography (LIE-CT) for assessment of severity and prognosis of patients with myocardial infarction | |
Scientific Title:Acronym | Feasibility of LIE-CT for detecting MI | |
Region |
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Condition | |||
Condition | coronary artery disease | ||
Classification by specialty |
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Classification by malignancy | Others | ||
Genomic information | NO |
Objectives | |
Narrative objectives1 | To evaluate the feasibility of late iodine enhancement computed tomography (LIE-CT) for assessment of severity and prognosis of patients with myocardial infarction |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Prognostic value of LIE-CT findings: total mortality, cardiac death, acute myocardial infarction, admission with coronary artery disease, target vessel revascularization, target lesion revascularization |
Key secondary outcomes | Feasibility of LIE-CT with ADMIRE in comparison with FBP and SAFIRE
Comparison study between diastole and systole LIE-CT Feasibility ofLIE-CT with image subtraction technique of left ventricular cavity Feasibility of combined assessment of coronary CT angiography (CTA), myocardial CT perfusion (CTP), and LIE-CT in comparison with fractional flow reserve (FFR), and instantaneous wave-free ratio (iFR) Comparison study of coronary CTA, and myocardial CTP with quantitative coronary arteriography (QCA), FFR, and iFR Prognostic value of myocardial CTP findings: total mortality, cardiac death, acute myocardial infarction, admission with coronary artery disease, target vessel revascularization, target lesion revascularization |
Base | |
Study type | Observational |
Study design | |
Basic design | |
Randomization | |
Randomization unit | |
Blinding | |
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Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
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Eligibility | ||||
Age-lower limit |
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Gender | Male and Female | |||
Key inclusion criteria | Patients with known/suspected coronary artery disease | |||
Key exclusion criteria | Acute coronary syndrome, unstable angina, malignant arrhythmia, severe left ventricular dysfunction, aortic valve stenosis
Old myocardial infarction Known allergic reaction to contrast media Known history of hyperthyroidism and bronchial asthma Chronic kidney disease Chronic atrial fibrillation Greater than first degree atrioventricular block, and sick sinus syndrome Patient with pacemaker and implantable cardioverter defibrillator Pregnancy Known allergic reaction to beta blocker |
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Target sample size | 100 |
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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 | ||||||
TEL | +81-89-960-5371 | ||||||
yuki.tanabe.0225@gmai.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 | ||||||
TEL | +81-89-960-5371 | ||||||
Homepage URL | |||||||
yuki.tanabe.0225@gmai.com |
Sponsor | |
Institute | Ehime University |
Institute | |
Department |
Funding Source | |
Organization | Nothing |
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 |
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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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Baseline Characteristics | |
Participant flow | |
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Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Open public recruiting | ||||||
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Other | |
Other related information | Prospective study |
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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=R000027953 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |