UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026943
Receipt number 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 09:05:37

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 or person

Institute

Kochi Medical School

Institute

Department

Personal name



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

Value
https://center6.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