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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000016641
Receipt No. R000019317
Scientific Title Benefits of assessment of coronary artery disease by coronary computed tomography angiography and various parameters
Date of disclosure of the study information 2015/02/25
Last modified on 2017/08/30

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Basic information
Public title Benefits of assessment of coronary artery disease by coronary computed tomography angiography and various parameters
Acronym CTA and various parameters
Scientific Title Benefits of assessment of coronary artery disease by coronary computed tomography angiography and various parameters
Scientific Title:Acronym CTA and various parameters
Region
Japan

Condition
Condition coronary artery disease
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We evaluated the relationship between various parameters [conventional cardiovascular risk factors (age, gender, obesity, smoking, hypertension, dyslipidemia, diabetes), blood pressure profile, lipid profile including high-density lipoprotein function, various biomarkers, brachial ankle pulse wave velocity, cardio ankle vascular index, flow mediated dilation] and the presence of coronary artery disease or the severity of coronary stenosis in patients who undergo coronary computed tomography angiography CTA. Moreover, we perform follow-up CTA after 3 years and analyze the relationship between various parameters and and the presence of coronary artery disease or the severity of coronary stenosis again.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Differences in various parameters [conventional cardiovascular risk factors, blood pressure profile, lipid profile, various biomarkers, brachial ankle pulse wave velocity, cardio ankle vascular index, flow mediated dilation and other biochemical parameters including inflammation makers between the presence and absence of coronary artery disease at baseline and follow-up.
Key secondary outcomes Associations between various parameters [conventional cardiovascular risk factors, blood pressure profile, lipid profile, various biomarkers, brachial ankle pulse wave velocity, cardio ankle vascular index, flow mediated dilation and other biochemical parameters including inflammation makers, telomere and telomere G-tail length] and the severity of coronary artery disease at baseline and follow-up.

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.Age is 20 years old or more.
2.Patients who gave their informed consent to participate for the present study.
Key exclusion criteria 1.Severe liver dysfunction
2.Severe renal dysfunction
3.Patients with a history of allergy to any component of contrast media 4.Patients corresponding to the contraindication of contrast media
5.Ineligible patients according to the judgment by physician
Target sample size 1200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shin-ichiro Miura
Organization Fukuoka University School of Medicine
Division name Department of Cardiology
Zip code
Address 7-45-1 Nanakuma, Jonan-Ku, Fukuoka.
TEL 81-92-801-1011
Email saku-k@fukuoka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shin-ichiro Miura
Organization Fukuoka University School of Medicine
Division name Department of Cardiology
Zip code
Address 7-45-1 Nanakuma, Jonan-Ku, Fukuoka.
TEL 81-92-801-1011
Homepage URL
Email miuras@cis.fukuoka-u.ac.jp

Sponsor
Institute Department of Cardiology, Fukuoka University School of Medicine
Institute
Department

Funding Source
Organization Department of Cardiology, Fukuoka University School of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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 福岡大学病院(福岡県)、白十字病院(福岡県)

Other administrative information
Date of disclosure of the study information
2015 Year 02 Month 25 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
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
2009 Year 08 Month 20 Day
Date of IRB
Anticipated trial start date
2009 Year 09 Month 01 Day
Last follow-up date
2023 Year 08 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Serum levels of glycated albumin may be superior to hemoglobin A1c as a marker for evaluating the presence of coronary artery disease.

Management information
Registered date
2015 Year 02 Month 25 Day
Last modified on
2017 Year 08 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019317

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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