UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041836
Receipt number R000047759
Scientific Title Ischemic Heart Disease Registry at Yokohama City University
Date of disclosure of the study information 2020/09/18
Last modified on 2020/09/18 10:19:42

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Ischemic Heart Disease Registry at Yokohama City University

Acronym

YCU-IHD Registry

Scientific Title

Ischemic Heart Disease Registry at Yokohama City University

Scientific Title:Acronym

YCU-IHD Registry

Region

Japan


Condition

Condition

Ischemic Heart Disease

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the natural course and the prognostic predictor of ischemic heart disease.

Basic objectives2

Others

Basic objectives -Others

To build the Registry database of ischemic heart disease.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Prognosis including death, non-fatal myocardial infarction, non-fatal stroke, bleeding, revascularization, heart failure, and arrhythmias.

Key secondary outcomes



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

This study is a retrospective and prospective observational study at Yokohama City University between April 2005 to December 2029.

Patients with the diagnosis of acute coronary syndrome (ST-segment elevation myocardial infarction, non ST-segment elevation myocardial infarction, unstable angina, cardiac sudden death), stable angina, silent myocardial ischemia, old myocardial infarction, and vasospastic angina are enrolled.

Key exclusion criteria

Rejection to the Registry.

Target sample size

5000


Research contact person

Name of lead principal investigator

1st name Kozo
Middle name
Last name Okada

Organization

Yokohama City University Medical Center

Division name

Division of cardiology

Zip code

232-0024

Address

4-57 Urafune-cho, Minami-ku, Yokohama

TEL

+81452615656

Email

kokada2@yokohama-cu.ac.jp


Public contact

Name of contact person

1st name Masaomi
Middle name
Last name Gohbara

Organization

Yokohama City University Graduate School of Medicine

Division name

Department of Medical Science and Cardiorenal Medicine

Zip code

236-0004

Address

3-9 Fukuura, Kanazawa-ku, Yokohama

TEL

+81457872800

Homepage URL


Email

gocchi3@yokohama-cu.ac.jp


Sponsor or person

Institute

Yokohama City University

Institute

Department

Personal name



Funding Source

Organization

Yokohama City University

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

Institutional Review Board of Yokohama City University

Address

3-9 Fukuura, Kanazawa-ku, Yokohama

Tel

+81453707627

Email

rinri@yokohama-cu.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 09 Month 18 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

2019 Year 12 Month 02 Day

Date of IRB

2020 Year 01 Month 06 Day

Anticipated trial start date

2020 Year 01 Month 06 Day

Last follow-up date

2029 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

[Component of an examination]
Patients characteristics
Physical findings
Laboratory data
Physiological examination (ECG, Echo, etc)
Imaging examination (CAG, MRI, X-dar, CT, RI, IVUS/OCT/OFDI)
Intervention findings


Management information

Registered date

2020 Year 09 Month 18 Day

Last modified on

2020 Year 09 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047759


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name