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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000043316
Receipt No. R000048847
Scientific Title Association of Thoracic Aortic Plaques on Coronary CT angiography With Short-term Cardiovascular Outcomes in Patients With Suspected Coronary Artery Disease
Date of disclosure of the study information 2021/02/13
Last modified on 2021/02/13

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Basic information
Public title Association of Thoracic Aortic Plaques on Coronary CT angiography With Short-term Cardiovascular Outcomes in Patients With Suspected Coronary Artery Disease
Acronym Association of Thoracic Aortic Plaques on Coronary CT angiography With Short-term Cardiovascular Outcomes in Patients With Suspected Coronary Artery Disease
Scientific Title Association of Thoracic Aortic Plaques on Coronary CT angiography With Short-term Cardiovascular Outcomes in Patients With Suspected Coronary Artery Disease
Scientific Title:Acronym Association of Thoracic Aortic Plaques on Coronary CT angiography With Short-term Cardiovascular Outcomes in Patients With Suspected Coronary Artery Disease
Region
Japan

Condition
Condition Patiennts with suspected coronary artery disease undergoing invasive coronary angiography or percutaneous coronary intervention
Classification by specialty
Cardiology Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate association of thoracic aortic plaques with a composite cardiovascular event
Basic objectives2 Others
Basic objectives -Others To investigate clinical significance of thoracic aortic plaques assessed by coronary computed tomography angiography
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes A composite event of symptomatic or asymptomatic brain infarction, acute kidney injury, cholesterol embolism, and all-cause death
Key secondary outcomes 1. A composite event of symptomatic or asymptomatic brain infarction, acute kidney injury, cholesterol embolism, and all-cause death, and PCI related myocardial infarction

2. Individual occurrence of the following items
Surgery or rupture for aortic aneurysm
Peripheral arterial disease (PAD) revascularization
Carotid artery stenting (CAS) and carotid endarterectomy (CEA)
Aortic dissection
Aortic valve stenosis surgery
Bypass surgery for coronary artery stenosis
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
20 years-old <=
Age-upper limit
95 years-old >=
Gender Male and Female
Key inclusion criteria Suspected CAD patients with CTCA undergoing CAG and/or PCI
Key exclusion criteria Patients for whom consent was not obtained
Patients requiring maintenance dialysis
patients with cardiogenic shock
Appropriate patients
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Kenichiro
Middle name
Last name Otsuka
Organization Fujiikai Kashibaseiki Hospital
Division name Division of Cardiology
Zip code 639-0252
Address Anamushi 3300-3 Kashiba, Nara, Japan
TEL +81-745-71-3113
Email otsukakenichiro1@gmail.com

Public contact
Name of contact person
1st name Kenichiro
Middle name
Last name Otsuka
Organization Fujiikai Kashibaseiki Hospital
Division name Division of Cardiology
Zip code 639-0252
Address Anamushi 3300-3 Kashiba, Nara, Japan
TEL +81-745-71-3113
Homepage URL
Email otsukakenichiro1@gmail.com

Sponsor
Institute Fujiikai Kashibaseiki Hospital
Institute
Department

Funding Source
Organization Fujiikai Kashibaseiki Hospital
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Fujiikai Kashibaseiki Hospital IRB
Address Anamushi 3300-3 Kashiba, Nara, Japan
Tel +81-745-71-3113
Email otsukakenichiro1@gmail.com

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 医療法人藤井会香芝生喜病院(奈良県)

Other administrative information
Date of disclosure of the study information
2021 Year 02 Month 13 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 Enrolling by invitation
Date of protocol fixation
2020 Year 12 Month 14 Day
Date of IRB
2020 Year 12 Month 14 Day
Anticipated trial start date
2020 Year 12 Month 14 Day
Last follow-up date
2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Observational study

Management information
Registered date
2021 Year 02 Month 13 Day
Last modified on
2021 Year 02 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048847

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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