UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033793 |
|---|---|
| Receipt number | 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 | 2025/08/08 11:34:14 |
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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
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
coupling@jichi.ac.jp
Sponsor or person
Institute
Jichi Medical University School of
Medicine
Institute
Department
Personal name
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
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
No longer recruiting
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
| 2025 | Year | 08 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038551
