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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001522
Receipt No. R000001837
Scientific Title Clinical Utility of Tissue Doppler Echocardiography in Prediction of Postoperative Arrhythmias Following Pulmonary Resection for Lung Cancer
Date of disclosure of the study information 2008/11/23
Last modified on 2014/12/15

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Basic information
Public title Clinical Utility of Tissue Doppler Echocardiography in Prediction of Postoperative Arrhythmias Following Pulmonary Resection for Lung Cancer
Acronym Tissue Doppler Echocardiography for Lung Cancer
Scientific Title Clinical Utility of Tissue Doppler Echocardiography in Prediction of Postoperative Arrhythmias Following Pulmonary Resection for Lung Cancer
Scientific Title:Acronym Tissue Doppler Echocardiography for Lung Cancer
Region
Japan

Condition
Condition Lung Cancer
Classification by specialty
Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the utility of tissue Doppler imaging in predicting the development of postoperative arrhythmias
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes the utility of tissue Doppler imaging in predicting the development of postoperative arrhythmais for lung cancer
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Consecutive patients who underwent pulmonary resections for lung cancer at Toneyama National Hospital
Key exclusion criteria rhythm other than sinus, dysthyroidism, renal failure requiring hemodialysis, current use of antiarrhythmic drugs, repeat pulmonary resections, moderate or severe valvular heart disease, and recent angina pectoris or myocardial infarction ( <1month)
Target sample size 110

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takashi Nojiri
Organization Toneyama National Hospital
Division name General Thoracic Surgery
Zip code
Address Toneyama 5-1-1,Toyonaka City, Osaka 560-8552,Japan
TEL 06-6853-2001
Email nojirit@thoracic.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takashi Nojiri
Organization Toneyama National Hospital
Division name General Thoracic Surgery
Zip code
Address Toneyama 5-1-1,Toyonaka City, Osaka 560-8552,Japan
TEL 06-6853-2001
Homepage URL
Email honnnori2003@yahoo.co.jp

Sponsor
Institute Toneyama National Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor None
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 Toneyama National Hospital

Other administrative information
Date of disclosure of the study information
2008 Year 11 Month 23 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.ncbi.nlm.nih.gov/pubmed/20691999
Number of participants that the trial has enrolled
Results Tissue Doppler imaging seems to be an appropriate tool in predicting the development of postoperative arrhythmias in patients with lung cancer.
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
2007 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2007 Year 08 Month 01 Day
Last follow-up date
2008 Year 11 Month 01 Day
Date of closure to data entry
2009 Year 03 Month 01 Day
Date trial data considered complete
2009 Year 03 Month 01 Day
Date analysis concluded
2009 Year 03 Month 01 Day

Other
Other related information Tissue Doppler imaging seems to be an appropriate tool in predicting the development of postoperative arrhythmias in patients with lung cancer.

Management information
Registered date
2008 Year 11 Month 23 Day
Last modified on
2014 Year 12 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001837

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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