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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001018
Receipt No. R000001229
Scientific Title Prevalence of chronic obstructive pulmonary disease in patients with coronary artery diseases
Date of disclosure of the study information 2008/02/08
Last modified on 2012/03/08

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Basic information
Public title Prevalence of chronic obstructive pulmonary disease in patients with coronary artery diseases
Acronym Prevalence of chronic obstructive pulmonary disease in patients with coronary artery diseases
Scientific Title Prevalence of chronic obstructive pulmonary disease in patients with coronary artery diseases
Scientific Title:Acronym Prevalence of chronic obstructive pulmonary disease in patients with coronary artery diseases
Region
Japan

Condition
Condition coronary artery disease and chronic obstructive pulmonary disease
Classification by specialty
Cardiology Pneumology
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To determine the prevalence of chronic obstructive pulmonary disease in Japanese patients with coronary artery diseases
Basic objectives2 Others
Basic objectives -Others To determine the prevalence of chronic obstructive pulmonary disease in Japanese patients with coronary artery diseases
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes prevalence of chronic obstructive pulmonary disease (FEV1%<70%) in patients with >75% stenosis of coronary arteries
Key secondary outcomes Risk factors for coexistence of coronary artery diseases and chronic obstructive pulmonary disease
Prognosis of patients with coronary artery disease and chronic obstructive pulmonary disease

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
40 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Japanese patients with possible coronary artery disease who admit to KEIO University hospital for the purpose of coronary angiography, and are hemodynamically stable.
Key exclusion criteria 1. patients with acute myocardial infarction, unstable angina, or dissecting aneurysm
2. patients with severe heart failure or arrythmia
3. patients who cardiologists consider inappropriate to perform spirometry
4. patients with asthma under active treatment
5. patients with extensive pulmonary disease on chest X-ray film
Target sample size 800

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koichiro Asano
Organization Keio University School of Medicine
Division name Division of Pulmonary Medicine
Zip code
Address 35 Shinanomachi, Shinjukuku, Tokyo
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Koichiro Asano
Organization Keio University School of Medicine
Division name Division of Pulmonary Medicine
Zip code
Address
TEL
Homepage URL
Email ko-asano@qa2.so-net.ne.jp

Sponsor
Institute Division of Pulmonary Medicine, Keio University School of Medicine
Institute
Department

Funding Source
Organization Division of Pulmonary Medicine, Keio University School of Medicine
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
2008 Year 02 Month 08 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
2008 Year 02 Month 06 Day
Date of IRB
Anticipated trial start date
2009 Year 04 Month 01 Day
Last follow-up date
2013 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information survival, QOL

Management information
Registered date
2008 Year 02 Month 06 Day
Last modified on
2012 Year 03 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001229

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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