UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024276 |
|---|---|
| Receipt number | 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 08:13:27 |
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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
| Japan |
Condition
Condition
coronary artery disease
Classification by specialty
| Cardiology | Radiology |
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
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
| 40 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
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
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
TEL
+81-89-960-5371
yuki.tanabe.0225@gmai.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
TEL
+81-89-960-5371
Homepage URL
yuki.tanabe.0225@gmai.com
Sponsor or person
Institute
Ehime University
Institute
Department
Personal name
Funding Source
Organization
Nothing
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027953
