UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015964 |
|---|---|
| Receipt number | R000018219 |
| Scientific Title | Feasibility of Computed Tomography Derived Myocardial Blood Flow Using Whole-Heart Dynamic Computed Tomography Perfusion Imaging: Differentiation of Myocardial Ischemia and Infarction Assessed by Comparison with Cardiac Magnetic Resonance and Single Photon Emission Computed Tomography |
| Date of disclosure of the study information | 2014/12/17 |
| Last modified on | 2017/02/09 12:43:21 |
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Basic information
Public title
Feasibility of Computed Tomography Derived Myocardial Blood Flow Using Whole-Heart Dynamic Computed Tomography Perfusion Imaging: Differentiation of Myocardial Ischemia and Infarction Assessed by Comparison with Cardiac Magnetic Resonance and Single Photon Emission Computed Tomography
Acronym
Feasibility of CT-MBF for distinguishing among normal, ischemic and infarcted myocardium
Scientific Title
Feasibility of Computed Tomography Derived Myocardial Blood Flow Using Whole-Heart Dynamic Computed Tomography Perfusion Imaging: Differentiation of Myocardial Ischemia and Infarction Assessed by Comparison with Cardiac Magnetic Resonance and Single Photon Emission Computed Tomography
Scientific Title:Acronym
Feasibility of CT-MBF for distinguishing among normal, ischemic and infarcted myocardium
Region
| Japan |
Condition
Condition
Coronary artery disease
Classification by specialty
| Cardiology | Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the feasibility of myocardial blood flow (MBF) derived from whole-heart dynamic myocardial computed tomography perfusion (CTP) imaging using 256-slice multidetector-row computed tomography (256-slice MDCT) with adenosine triphosphate (ATP) stress in the detection of myocardial perfusion abnormalities (ischemia and infarction) on conventional myocardial perfusion imaging (SPECT and cardiac MR).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Differentiation of CT-derived MBF among normal, ischemic and infarcted myocardium in patient groups of SPECT and cardiac MR, respectively.
Diagnostic accuracy of CT-derived MBF for detecting myocardial perfusion abnormality on SPECT and cardiac MR.
Key secondary outcomes
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
(1) Patients who give a full consent to this study
(2) Effort or resting angina (chest pain, documented ST-T change on electrocardiogram [ECG], or symptoms relieved by administration of nitroglycerin)
(3) Asymptomatic patients with multiple coronary risk factors for CAD.
(4) All patients perform ATP-stree dynamic myocardial CT perfusion and myocardial perfusion imaging (SPECT or cardiac MRI) within a month.
Key exclusion criteria
(1) acute myocardial infarction
(2) cardiomyopathy
(3) severe left ventricular dysfunction (ejection fraction < 20%)
(4) chronic atrial fibrillation
(5) greater than first degree atrio-ventricular block
(6) symptomatic congestive heart failure of New York Heart Association class IV
(7)percutaneous coronary intervention
(8) history of coronary artery bypass graft
(9) hypotension (systolic blood pressure < 90 mm Hg)
(10) severe chronic obstructive pulmonary disease
(11) chronic kidney disease (serum creatinine > 1.5 mg/dl)
(12) pregnancy
(13) known history of hyperthyroidism and bronchial asthma
(14) known hypersensitivity to contrast media.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuki Tanabe |
Organization
Ehime University Graduate School of Medicine.
Division name
Department of Radiology
Zip code
Address
Shitsukawa, Toon, Ehime, Japan
TEL
089-960-5371
yuki.tanabe.0225@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuki Tanabe |
Organization
Ehime University Graduate School of Medicine.
Division name
Department of Radiology
Zip code
Address
Shitsukawa, Toon, Ehime, Japan
TEL
089-960-5371
Homepage URL
yuki.tanabe.0225@gmail.com
Sponsor or person
Institute
Ehime University Graduate 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
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
| 2014 | Year | 12 | Month | 17 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Completed
Date of protocol fixation
| 2010 | Year | 04 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 05 | Month | 25 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective study]
Management information
Registered date
| 2014 | Year | 12 | Month | 16 | Day |
Last modified on
| 2017 | Year | 02 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018219
