UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022331
Receipt number R000025730
Scientific Title Reliability of portable metabolic gas analyzer in patients with heart disease
Date of disclosure of the study information 2016/05/17
Last modified on 2019/05/19 21:45:33

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Basic information

Public title

Reliability of portable metabolic gas analyzer in patients with heart disease

Acronym

Reliability of portable metabolic gas analyzer in patients with heart disease

Scientific Title

Reliability of portable metabolic gas analyzer in patients with heart disease

Scientific Title:Acronym

Reliability of portable metabolic gas analyzer in patients with heart disease

Region

Japan


Condition

Condition

Ischemic heart disease

Classification by specialty

Cardiology Cardiovascular surgery Rehabilitation medicine
Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is verify the reliability of the portable metabolic gas analyzer as a target for heart disease patients, by comparing the portable metabolic gas analyzer (AE-100i Minato Medical Science CO.,Ltd.) which has developed recently and the stationary metabolic gas analyzer (AE-300S Minato Medical Science CO.,Ltd.) which is frequently used in Japan.

Basic objectives2

Others

Basic objectives -Others

Measuring instrument of reliability

Trial characteristics_1

Others

Trial characteristics_2

Others

Developmental phase

Not applicable


Assessment

Primary outcomes

Peak VO2(Maximum oxygen uptake), AT(anaerobic threshold),VE vs VCO2 slope,delta V02/delta WR etc

Key secondary outcomes

Blood pressure,Heart rate,ECG changes


Base

Study type

Others,meta-analysis etc


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


Not applicable

Gender

Male

Key inclusion criteria

・Patients who consent to this study can be obtained in writing.
・The patient before discharge from the hospital who is hospitalized by acute myocardial infarction or angina, has performed percutaneous coronary intervention or coronaly artery bypass and has ended acute phase rehabilitation.

Key exclusion criteria

・Patient with medical history which hinders exercise.
・The person throwing the medicine which influences a result of the cardio pulmonary exercise test.

Target sample size

15


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yohei Toyama

Organization

Saitama Medical university International Medical Center

Division name

Department of rehabilitation medicine

Zip code


Address

1397-1 Yamane Hidaka City Saitama Japan

TEL

049-984-4367

Email

yohei_t@saitama-med.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yohei Toyama

Organization

Saitama Medical university International Medical Center

Division name

Department of rehabilitation medicine

Zip code


Address

1397-1 Yamane Hidaka City Saitama Japan

TEL

049-984-4367

Homepage URL


Email

yohei_t@saitama-med.ac.jp


Sponsor or person

Institute

Saitama Medical university International Medical Center

Institute

Department

Personal name



Funding Source

Organization

Self-funding

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

2016 Year 05 Month 17 Day


Related information

URL releasing protocol


Publication of results

Unpublished


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

Terminated

Date of protocol fixation

2015 Year 12 Month 18 Day

Date of IRB

2015 Year 12 Month 02 Day

Anticipated trial start date

2016 Year 05 Month 17 Day

Last follow-up date

2017 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

The study ended because there were no cases.


Management information

Registered date

2016 Year 05 Month 17 Day

Last modified on

2019 Year 05 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025730


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name