UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000001018
Receipt number 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 16:14:38

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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 or person

Institute

Division of Pulmonary Medicine, Keio University School of Medicine

Institute

Department

Personal name



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

Value
https://center6.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