UMIN-CTR Clinical Trial

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 Shin-ichiro Middle name Last name Miura
Organization	Fukuoka University School of Medicine
Division name	Department of Cardiology
Zip code	8140180
Address	7-45-1 Nanakuma, Jonan-Ku, Fukuoka.
TEL	0928011011
Email	miuras@cis.fukuoka-u.ac.jp

Public contact
Name of contact person	1st name Shin-ichiro Middle name Last name Miura
Organization	Fukuoka University School of Medicine
Division name	Department of Cardiology
Zip code	8140180
Address	7-45-1 Nanakuma, Jonan-Ku, Fukuoka.
TEL	0928011011
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	Fukuoka Univ. Clinical Research & Ethics Centre
Address	7-45-1 Nanakuma, Jonan-Ku, Fukuoka, Japan.
Tel	0928011011
Email	miuras@cis.fukuoka-u.ac.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	福岡大学病院（福岡県）、白十字病院（福岡県）、福岡大学西新病院（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	2009 Year 10 Month 02 Day
Anticipated trial start date	2009 Year 11 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	2021 Year 03 Month 01 Day

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