UMIN-CTR Clinical Trial

Basic information
Public title	A prospective observational study of changes in coronary plaque and heart valve calcification after 2 years in patients with moderate coronary stenosis
Acronym	A prospective observational study of changes in coronary plaque and heart valve calcification after 2 years in patients with moderate coronary stenosis
Scientific Title	A prospective observational study of changes in coronary plaque and heart valve calcification after 2 years in patients with moderate coronary stenosis
Scientific Title:Acronym	A prospective observational study of changes in coronary plaque and heart valve calcification after 2 years in patients with moderate coronary stenosis
Region	Japan

Condition
Condition	Coronary atherosclerosis
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To observe patients with moderate or higher stenosis of the coronary arteries over time by coronary CT to investigate the progression and changes in plaque volume and properties and related factors. We will also observe the association of coronary atherosclerosis with the progression of heart valve calcification over time and related factors.
Basic objectives2	Others
Basic objectives -Others	Observation of changes in lesions
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	(1)Factors related to changes in plaque in the coronary arteries during 2 years (2)Factors related to the occurrence of cardiovascular events (cardiac death, non-fatal myocardial infarction, hospitalization due to unstable angina)
Key secondary outcomes	Factors associated with changes in heart valve calcification during 2 years

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	35 years-old <=
Age-upper limit	75 years-old >=
Gender	Male and Female
Key inclusion criteria	(1)Continuous cases in which patients who can take coronary CT scan without a history of coronary artery disease, contrast medium allergy, or asthma. (2)Patients who gave informed consent.
Key exclusion criteria	(1)Cases in which coronary CT images are poor and difficult to evaluate (2)In addition, those who are judged to be inappropriate as research subjects by reserchers.
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Fujimoto Middle name Last name Shinichiro
Organization	Juntendo University Graduate School of Medicine
Division name	Department of Cardiovascular Biology and Medicine
Zip code	113-8431
Address	3-1-3 Hongo, Bunkyo-ku, Tokyo
TEL	03-3813-3111
Email	snfujimo@juntendo.ac.jp

Public contact
Name of contact person	1st name Fujimoto Middle name Last name Shinichiro
Organization	Juntendo University Graduate School of Medicine
Division name	Department of Cardiovascular Biology and Medicine
Zip code	113-8431
Address	3-1-3 Hongo, Bunkyo-ku, Tokyo
TEL	03-3813-3111
Homepage URL
Email	snfujimo@juntendo.ac.jp

Sponsor
Institute	Juntendo University Graduate School of Medicine
Institute
Department

Funding Source
Organization	No
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Juntendo Clinical Research and Trial Center
Address	3-1-3 Hongo, Bunkyo-ku, Tokyo
Tel	03-3814-5672
Email	kenkyu5858@juntendo.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

Other administrative information
Date of disclosure of the study information	2020 Year 10 Month 10 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	Open public recruiting
Date of protocol fixation	2020 Year 08 Month 28 Day
Date of IRB	2020 Year 08 Month 28 Day
Anticipated trial start date	2020 Year 10 Month 01 Day
Last follow-up date	2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	To observe patients with moderate or higher stenosis of the coronary arteries over time by coronary CT to investigate the progression and changes in plaque volume and properties and related factors. We will also observe the association of coronary atherosclerosis with the progression of heart valve calcification over time and related factors.

Management information
Registered date	2020 Year 10 Month 08 Day
Last modified on	2020 Year 10 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047990