UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016641 |
|---|---|
| Receipt number | 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 | 2021/03/01 09:30:27 |
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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 | 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
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
miuras@cis.fukuoka-u.ac.jp
Sponsor or person
Institute
Department of Cardiology, Fukuoka University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019317
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
