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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026943
Receipt No. R000030905
Scientific Title Evaluation of the QRS amplitude of the limb lead I in patients with chronic obstructive pulmonary disease
Date of disclosure of the study information 2017/12/20
Last modified on 2019/10/15

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Basic information
Public title Evaluation of the QRS amplitude of the limb lead I in patients with chronic obstructive pulmonary disease
Acronym Characteristics of ECG in COPD patients
Scientific Title Evaluation of the QRS amplitude of the limb lead I in patients with chronic obstructive pulmonary disease
Scientific Title:Acronym Characteristics of ECG in COPD patients
Region
Japan

Condition
Condition Chronic obstructive pulmonary disease (COPD)
Classification by specialty
Cardiology Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Estimation of ECG cut-off values in patients with early COPD
Basic objectives2 Others
Basic objectives -Others Low voltage
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Cut-off value of QRS amplitude in the limb lead I
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
45 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria (1) Patients diagnosed at the Kochi Medical School Hospital from October 2009 to March 2014
(2) FEV1/FVC < 0.70 after bronchodilator use
(3) normal sinus rhythm and free of heart diseases and respiratory diseases other than COPD
Key exclusion criteria (1) Less than 45 years old
(2) Respiratory diseases other than COPD
(3) Dyslipidemia
(4) Diabetes
(5) Heart failure
Target sample size 82

Research contact person
Name of lead principal investigator
1st name Atsushi
Middle name
Last name Ichikawa
Organization Kochi Medical School
Division name Department of Cardiovascular Control
Zip code 783-8505
Address Kohasu, Oko-cho, Nankoku-shi, Kochi 783-8505, Japan
TEL 088-880-2587
Email ichik@kochi-u.ac.jp

Public contact
Name of contact person
1st name Atsushi
Middle name
Last name Ichikawa
Organization Kochi Medical School
Division name Department of Cardiovascular Control
Zip code 783-8505
Address Kohasu, Oko-cho, Nankoku-shi, Kochi 783-8505, Japan
TEL 088-880-2587
Homepage URL
Email ichik@kochi-u.ac.jp

Sponsor
Institute Kochi Medical School
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Ethical review board of kochi medical school
Address Kohasu, Oko-cho, Nankoku-shi, Kochi 783-8505, Japan
Tel 088-880-2180
Email rinri21@kochi-u.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

Other administrative information
Date of disclosure of the study information
2017 Year 12 Month 20 Day

Related information
URL releasing protocol https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000030905
Publication of results Unpublished

Result
URL related to results and publications https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000030905
Number of participants that the trial has enrolled 82
Results
Respiratory function test
ECG
Results date posted
2019 Year 10 Month 15 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients with COPD
Participant flow
Retrospective study
Adverse events
no
Outcome measures
Respiratory function test
ECG
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2017 Year 01 Month 19 Day
Date of IRB
2017 Year 01 Month 19 Day
Anticipated trial start date
2017 Year 01 Month 19 Day
Last follow-up date
2018 Year 02 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Retrospective observational study

Management information
Registered date
2017 Year 04 Month 11 Day
Last modified on
2019 Year 10 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030905

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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