UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000024245
Receipt No. 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 (Ver. 7)

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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
Email 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
Email tomizawa-tky@umin.ac.jp

Sponsor
Institute New Tokyo Hospital
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027903