UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016957 |
|---|---|
| Receipt number | R000019682 |
| Scientific Title | Clinical significance of RH index in hypertensive patients |
| Date of disclosure of the study information | 2015/03/28 |
| Last modified on | 2015/03/28 10:06:10 |
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Basic information
Public title
Clinical significance of RH index in hypertensive patients
Acronym
Endothelial dysfunction in essential hypertension
Scientific Title
Clinical significance of RH index in hypertensive patients
Scientific Title:Acronym
Endothelial dysfunction in essential hypertension
Region
| Japan |
Condition
Condition
Hypertension
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Risk stratification of hypertensive patients by peripheral endothelial function
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The presence and severity of coronary artery disease
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
| 18 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
hypertensive patinets with at least one coronary risk factor
Key exclusion criteria
severe congestive heart failure
acute coronary syndrome
active inflammatory disease
past history of malignant disease
Target sample size
1300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yamamoto Eiichiro |
Organization
Kumamoto University Hospital
Division name
Cardiovascular Medicine
Zip code
Address
1-1-1 Honjo, Kumamoto, Japan
TEL
81-96-373-5175
eyamamo@kumamoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yamamoto Eiichiro |
Organization
Kumamoto University Hospital
Division name
Cardiovascular Medicine
Zip code
Address
1-1-1 Honjo, Kumamoto, Japan
TEL
81-96-373-5175
Homepage URL
eyamamo@kumamoto-u.ac.jp
Sponsor or person
Institute
Department of Cardiovascular Medicine, Kumamoto University Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Cardiovascular Medicine, Kumamoto University Hospital
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
Address
Tel
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
熊本大学医学部附属病院（熊本県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 03 | Month | 28 | 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
We demontrated the clinical significance of peripheral vascular function assesements in stable hypertensive patients for risk stratification of coronary artery disease.
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
Completed
Date of protocol fixation
| 2005 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2014 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 01 | Month | 15 | Day |
Date analysis concluded
| 2015 | Year | 01 | Month | 15 | Day |
Other
Other related information
Combining RH index to conventional coronary risk factors significantly improved AUC of ROC curve in predicting the presence of coronary artery disease.
Management information
Registered date
| 2015 | Year | 03 | Month | 28 | Day |
Last modified on
| 2015 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019682
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
