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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000018474
Receipt No. R000021342
Scientific Title Cardiovascular prognostic coupling study in Japan
Date of disclosure of the study information 2015/07/29
Last modified on 2019/08/01

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Basic information
Public title Cardiovascular prognostic coupling study in Japan
Acronym Cardiovascular prognostic coupling study in Japan(Coupling Registry)
Scientific Title Cardiovascular prognostic coupling study in Japan
Scientific Title:Acronym Cardiovascular prognostic coupling study in Japan(Coupling Registry)
Region
Japan

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

Objectives
Narrative objectives1 This study aimed to clarify the relationship between the blood pressure variability and vascular properties in hypertensive, and to investigate its relationships with the onset of cardiovascular events in patients at high risk of cardiovascular disease.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Time to major cardiovascular events*.
*Major cardiovascular events; a composite of cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage, unknown type of stroke,
myocardial infarction, cardiovascular intervention due to angina pectoris, and sudden death.
Key secondary outcomes 1. Time to various events onset*.
* In addition to each component of major cardiovascular events, followings are considered as "various events": hospitalization by angina pectoris; hospitalization by heart failure, aortic dissection; occlusive arteriosclerosis; end stage renal insufficiency; doubling of serum creatinine values; new onset of atrial fibrillation; dementia; need of nursing care; total death.
2. Change in blood pressure
3. Increase of CAVI or ABI value.
4. Development of left ventricular hypertrophy
5. Adverse event

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
30 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patient with at least one of the following cardiovascular risk factor:
1. Diabetes, glucose tolerance disorder
2. Dyslipidemia
3. high-normal normotension and grade I - III hypertension (>130/85 mmHg)
4. Current smoking
5. Renal disease (eGFR <= 60 or positive proteinuria)
6. Past history of cardiovascular disease (coronary artery disease, cerebrovascular disorder or non-cardiogenic cerebrovascular disorder, aortic dissection, peripheral artery disease, history of hospitalization by heart failure)
7. atrial fibrillation
8. Metabolic syndrome
9. Chronic obstructive pulmonary disease
10. Sleep apnea syndrome
Key exclusion criteria 1. Patients with chronic renal failure in haemodialysis
2. Other seriously ill patients (e.g. end stage of cancer, active connective tissue disease)
3. Alcohol addiction
4. Drug addiction
5. Patients who cannot visit a hospital alone by walk
6. Patients who cannot give informed consent by themselves
7. Patients who are judged to be inappropriate for the study by physician
Target sample size 7000

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 329-0498
Address 3311-1 Yakushiji, Shimotsuke, Tochigi 329-0498,Japan.
TEL 0285-58-7344
Email kkario@jichi.ac.jp

Public contact
Name of contact person
1st name Kazuomi
Middle name
Last name Kario
Organization Jichi Medical University School of
Division name Division of Cardiovascular Medicine, Department of Medicine
Zip code 329-0498
Address 3311-1 Yakushiji, Shimotsuke, Tochigi 329-0498,Japan.
TEL 0285-58-7344
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 Japan

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

IRB Contact (For public release)
Organization Jichi Medical School clinical study support center
Address 3311-1 Yakushiji, Shimotsuke, Tochigi 329-0498, 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 鷲谷病院(栃木県)、フクダ電子株式会社(東京都)、今別町国民健康保険今別診療所(青森県)、
沖縄県立中部病院(沖縄県)、遠賀中間医師会おんが病院(福岡県)、かわしま循環器内科(栃木県)、
久保田クリニック(東京都)、小竹町立病院(福岡県)、東吾妻町国民健康保険診療所(群馬県)、
藤田脳神経外科医院(香川県)、南三陸病院(宮城県)、山際クリニック(愛知県)、
周防大島町立東和病院(山口県)、岩国市医療センター医師会病院(山口県)、
まつい内科クリニック(山口県)、石橋内科医院(茨城県)、阿部内科医院(兵庫県)、
佐久総合病院佐久医療センター(長野県)、南和歌山医療センター(和歌山県)、表参道内科眼科(東京都)、
JCHOうつのみや病院(栃木県)、富士通クリニック(神奈川県)、
馬渡島診療所(佐賀県)、八代市椎原診療所(熊本県)、国民健康保険大間病院(青森県)、
大島診療所(福岡県)、国際医療福祉大学病院(栃木県)、結城病院(茨城県)、新小山市民病院(栃木県)、
とちぎメディカルセンターしもつが(栃木県)

 

Other administrative information
Date of disclosure of the study information
2015 Year 07 Month 29 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 6068
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 No longer recruiting
Date of protocol fixation
2015 Year 03 Month 26 Day
Date of IRB
2015 Year 03 Month 26 Day
Anticipated trial start date
2015 Year 07 Month 29 Day
Last follow-up date
2027 Year 10 Month 31 Day
Date of closure to data entry
2028 Year 01 Month 31 Day
Date trial data considered complete
2028 Year 03 Month 31 Day
Date analysis concluded
2029 Year 03 Month 31 Day

Other
Other related information This is a prospective cohort study.
Follow up period: Seven years.
Patients are followed up regularly for seven years every one year from a registration day.

Management information
Registered date
2015 Year 07 Month 29 Day
Last modified on
2019 Year 08 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021342

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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