UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015856 |
|---|---|
| Receipt number | R000018451 |
| Scientific Title | Detection of myocardial ischemia by CT perfusion imaging in comparison with N-13 ammonia PET |
| Date of disclosure of the study information | 2014/12/05 |
| Last modified on | 2016/03/24 09:53:53 |
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Basic information
Public title
Detection of myocardial ischemia by CT perfusion imaging in comparison with N-13 ammonia PET
Acronym
Myocardial CT perfusion versus N-13 ammonia PET
Scientific Title
Detection of myocardial ischemia by CT perfusion imaging in comparison with N-13 ammonia PET
Scientific Title:Acronym
Myocardial CT perfusion versus N-13 ammonia PET
Region
| Japan |
Condition
Condition
coronary artery disease
Classification by specialty
| Cardiology | Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine diagnostic accuracy of CT perfusion imaging for detecting myocardial ischemia in comparison with N-13 ammonia PET imaging
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Diagnostic accuracy of combination of CT perfusion and CT coronary angiography for detecting myocardial ischemia
Key secondary outcomes
Base
Study type
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Cardiac CT and N-13 ammonia PET for patients with coronary artery disease
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
| 45 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Subjects with written informed consent
Key exclusion criteria
1. Body weight >75kg
2. Elevated serum creatinine (>1.5 mg/dL) or calculated creatinine clearance of <60 mL/min
3. History of allergic reaction to iodinated contrast media, History of contrast-induced nephropathy
4. Atrial fibrillation or uncontrolled tachyarrhythmia
5. Advanced atrioventricular block (second- or third-degree heart block)
6. Evidence of acute coronary syndrome
7. Known or suspected moderate or severe aortic stenosis
8. Evidence of severe symptomatic heart failure (New York Heart Association class III or IV)
9. Previous coronary artery bypass or other cardiac surgery
10. Coronary artery intervention within the past 6 months
11. Contraindications to vasodilatory stress (systolic blood pressure <90, recent use of dipyridamole- and
dipyridamole-containing medications, recent use of
methylxanthines, such as aminophylline and caffeine)
12. Profound sinus bradycardia (fewer than 40 beats per minute)
13. Known or suspected intolerance or contraindication to beta-blockers (including known allergy to betablockers, history of moderate to severe bronchospastic lung disease, including moderate to severe asthma, severe pulmonary disease with the use of inhaled bronchodilator over the past year)
14. Presence of intracardiac devices, such as intracardiac defibrillator or metallic implants within the imaging field of view
15. History of high radiation exposure (>2 nuclear or multidetector CT studies) in the 1 month before consent
16. The presence of any other history or condition that the investigator judged to be a significant reason for
exclusion
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Chisato Kondo |
Organization
Tokyo Women's Medical University
Division name
Department of Diagnostic Imaging and Nuclear Medicine
Zip code
Address
8-1, Kawada-cho, Shinnjyuku-ku, Tokyo
TEL
03-3353-8111
kondo.chisato@twmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Chisato Kondo |
Organization
Tokyo Women's Medical University
Division name
Department of Diagnostic Imaging and Nuclear Medicine
Zip code
Address
8-1, Kawada-cho, Shinnjyuku-ku, Tokyo
TEL
03-3353-8111
Homepage URL
kondo.chisato@twmu.ac.jp
Sponsor or person
Institute
Tokyo Women's Medical University
Institute
Department
Personal name
Funding Source
Organization
National funding for scientific researches
Organization
Division
Category of Funding Organization
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 | 05 | 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
Completed
Date of protocol fixation
| 2013 | Year | 06 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 02 | Month | 29 | Day |
Date trial data considered complete
| 2016 | Year | 02 | Month | 29 | Day |
Date analysis concluded
| 2016 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 12 | Month | 05 | Day |
Last modified on
| 2016 | Year | 03 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018451
| Research Plan | |
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| Registered date | File name |
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