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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016917
Receipt No. R000019636
Scientific Title Clinical Significance of Pulse Pressure in Patients with Coronary Artery Disease
Date of disclosure of the study information 2015/03/26
Last modified on 2015/09/28

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Basic information
Public title Clinical Significance of Pulse Pressure in Patients with Coronary Artery Disease
Acronym Pulse pressure and coronary artery disease and future cardiovascular events
Scientific Title Clinical Significance of Pulse Pressure in Patients with Coronary Artery Disease
Scientific Title:Acronym Pulse pressure and coronary artery disease and future cardiovascular events
Region
Japan

Condition
Condition Coronary Artery Disease
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the relationship betweenpulse pressure and cardiovascular events in patient with coronary artery disease
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Composite endopoint of cardiovascular death, non-fatal myocardial infarction, unstable angina pectoris, non-fatal ischemic stroke, re-hospitalization for heart failure, or coronary revascularization
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
85 years-old >
Gender Male and Female
Key inclusion criteria Patients with more than 75% coronary artery stenosis by coronary angiography
Key exclusion criteria Urgently hospitalization patients
Chronic heart failure with reduced
ejectiionfraction
Severe valvular disease
History of malignancy
CKD patients who underwent Hemodialysis
Systemic inflammation disease
Anatomical abnormality for defect of arm or paralysis for stroke
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hisao Ogawa
Organization Graduate School of Medical Sciences, Kumamoto University
Division name Department of Cardiovascular Medicine
Zip code
Address 1-1-1 Honjo, Kumamoto City, JAPAN
TEL 81-96-373-5175
Email cvmhisho@kumamoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takanori Tokitsu
Organization Graduate School of Medical Sciences, Kumamoto University
Division name Department of Cardiovascular Medicine
Zip code
Address 1-1-1 Honjo, Kumamoto City, JAPAN
TEL 81-96-373-5175
Homepage URL
Email tokitsutakanori@gmail.com

Sponsor
Institute Kumamoto University
Institute
Department

Funding Source
Organization Kumamoto 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
Address
Tel
Email

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
2015 Year 03 Month 26 Day

Related information
URL releasing protocol
Publication of results Published

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 Completed
Date of protocol fixation
2006 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2007 Year 01 Month 08 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Patients were followed prospectively every month at the outpatient clinic until October 2013 or until an endpoint occurred

Management information
Registered date
2015 Year 03 Month 26 Day
Last modified on
2015 Year 09 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019636

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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