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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000033793
Receipt No. R000038551
Scientific Title Prospective study of predictive value in atherosclerotic indicators and electrocardiogram changes in patients with cardiovascular disease
Date of disclosure of the study information 2018/08/17
Last modified on 2020/04/03

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Basic information
Public title Prospective study of predictive value in atherosclerotic indicators and electrocardiogram changes in patients with cardiovascular disease
Acronym Coupling-ONE Registry
Scientific Title Prospective study of predictive value in atherosclerotic indicators and electrocardiogram changes in patients with cardiovascular disease
Scientific Title:Acronym Coupling-ONE Registry
Region
Japan

Condition
Condition Cardiovascular disease
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the relationship between arteriosclerotic indicators and electrocardiogram change and cardiovascular events in cardiovascular disease patients.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Major composite cardiovascular events
* Major composite cardiovascular events are cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage, stroke of unknown type, myocardial infarction, cardiac intervention by angina pectoris, hospitalization for heart failure, sudden death.
Key secondary outcomes Various events and period to onset of the events
* Various events include major composite cardiovascular events, aortic dissection, arteriosclerosis obliterans, end stage renal failure, new onset of atrial fibrillation, dementias, requiring nursing care, death from any cause are considered.

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 Patients with any of the following cardiovascular diseases
1. Angina pectoris
2. Myocardial infarction
3. Arrhythmia
4. Heart failure
5. Peripheral vascular disease
6. Aortic dissection / aortic aneurysm
7. Hypertension
8. Valvular heart disease
Key exclusion criteria 1. Patients without written informed consent
2. Active infections, with malignant tumors
3. Patients who are judged to be inappropriate for the study by attending physician
Target sample size 2000

Research contact person
Name of lead principal investigator
1st name Kazuomi
Middle name
Last name Kario
Organization Jichi Medical University School of
Medicine
Division name Division of Cardiovascular Medicine, Department of Medicine
Zip code 3290498
Address 3311-1 Yakushiji, Shimotsuke,Tochigi 329-0498, Japan.
TEL 0285-58-7538
Email kkario@jichi.ac.jp

Public contact
Name of contact person
1st name secretariat
Middle name
Last name Coupling study
Organization Jichi Medical University School of Medicine
Division name Division of Cardiovascular Medicine, Department of Medicine
Zip code 3290498
Address 3311-1 Yakushiji, Shimotsuke, Tochigi 329-0498, Japan.
TEL 0285-44-2130
Homepage URL
Email coupling@jichi.ac.jp

Sponsor
Institute Jichi Medical University School of
Medicine
Institute
Department

Funding Source
Organization Community Medicine Cardiovascular
Research Asia IT Network Center,
Division of Cardiovascular Medicine
Jichi Medical University School of
Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor FUKUDA DENSHI CO.,LTD.
Name of secondary funder(s)

IRB Contact (For public release)
Organization Jichi Medical University Hospital Clinical Research Ethics Committee A
Address 3311-1, Yakushiji, Shimotsuke, Tochigi, Japan
Tel 0285-58-8933
Email rinri@jichi.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 自治医科大学附属病院(栃木県)

Other administrative information
Date of disclosure of the study information
2018 Year 08 Month 17 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 Enrolling by invitation
Date of protocol fixation
2018 Year 03 Month 08 Day
Date of IRB
2018 Year 03 Month 08 Day
Anticipated trial start date
2019 Year 04 Month 01 Day
Last follow-up date
2029 Year 01 Month 31 Day
Date of closure to data entry
2029 Year 04 Month 30 Day
Date trial data considered complete
2029 Year 06 Month 30 Day
Date analysis concluded
2030 Year 06 Month 30 Day

Other
Other related information Design: Prospective observational study
Research subject: inpatients at Jichi Medical University Hospital Cardiovascular Center
CAVI will be measured during hospitalization.
Follow-up survey will be conducted every year for 5 years after discharge from the hospital.

Management information
Registered date
2018 Year 08 Month 17 Day
Last modified on
2020 Year 04 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038551

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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