UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042048
Receipt number R000047990
Scientific Title A prospective observational study of changes in coronary plaque and heart valve calcification after 2 years in patients with moderate coronary stenosis
Date of disclosure of the study information 2020/10/10
Last modified on 2020/10/08 11:19:38

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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 or person

Institute

Juntendo University Graduate School of Medicine

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047990


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name