UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024245 |
|---|---|
| Receipt number | R000027903 |
| Scientific Title | Stress myocardial perfusion CT during coronary CT exam |
| Date of disclosure of the study information | 2016/09/30 |
| Last modified on | 2020/03/25 21:32:12 |
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Basic information
Public title
Stress myocardial perfusion CT during coronary CT exam
Acronym
The utility of stress myocardial CTP
Scientific Title
Stress myocardial perfusion CT during coronary CT exam
Scientific Title:Acronym
The utility of stress myocardial CTP
Region
| Japan |
Condition
Condition
apnea, myocardial infarction, diabetes mellitus, hypertension, dyslipidemia
Classification by specialty
| Cardiology | Endocrinology and Metabolism | Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Myocardial ischemia and myocardial blood flow could be measured by adding stress dynamic myocardial CT perfusion to coronary CT angiography. The objective is to investigate the effect of these parameters on the prognosis and diagnosis of angina.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
MACE over a two-year period after the exam. Follow-up period might be extended when the event rate was lower than expected.
Key secondary outcomes
Assess patients who are eligible for stress myocardial CT perfusion.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Diabetes mellitus patients
2. If non-DM, patients with intermediate to high risk of coronary artery disease by Morise risk factor
3. Post percutaneous coronary intervention
Key exclusion criteria
1. Severe renal dysfunction
2. Active asthma
3. Allergy to contrast medium
4. Severe block
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Nobuo |
| Middle name | |
| Last name | Tomizawa |
Organization
New Tokyo Hospital
Division name
Department of Radiology
Zip code
2702232
Address
1271 Wanagaya, Matsudo, Chiba
TEL
047-711-8700
tomizawa-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Nobuo |
| Middle name | |
| Last name | Tomizawa |
Organization
New Tokyo Hospital
Division name
Department of Radiology
Zip code
2702232
Address
1271 Wanagaya, Matsudo, Chiba
TEL
047-711-8700
Homepage URL
tomizawa-tky@umin.ac.jp
Sponsor or person
Institute
New Tokyo Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB of New Tokyo Hospital
Address
1271 Wanagaya, Matsudo, Chiba
Tel
+81477118700
t-akutsu@sth-medical.co.jp
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 | 09 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
347
Results
1. Tomizawa N, Fujino Y, Kamitani M, et al. Longer diabetes duration reduces myocardial blood flow in remote myocardium assessed by dynamic myocardial CT perfusion. J Diabetes Complications. 2018 epub ahead of print
Results date posted
| 2020 | Year | 03 | Month | 25 | Day |
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
| 2016 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 02 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2016 | Year | 09 | Month | 30 | Day |
Last modified on
| 2020 | Year | 03 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027903
