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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000003018
Receipt No. R000003445
Scientific Title Speckle Tracking imaging for the Assessment of cardiac Resynchronization Therapy
Date of disclosure of the study information 2010/02/01
Last modified on 2010/01/12

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Basic information
Public title Speckle Tracking imaging for the Assessment of cardiac Resynchronization Therapy
Acronym START study
Scientific Title Speckle Tracking imaging for the Assessment of cardiac Resynchronization Therapy
Scientific Title:Acronym START study
Region
Japan

Condition
Condition Heart failure
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To determine the utility of two-dimensional speckle tracking echocardiographic parameter to analyze the effectiveness of cardiac resynchronization therapy.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Left ventricular endsystolic volume reduction (>15%)after 6 month and Improvement of NYHA class after 6 month
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Heart failure patients who is treated with CRT/CRT-D according to the Japanease Circulation Society guideline.
Key exclusion criteria 1) less than 20 year old age
2)no informed consent
3)chronic atrial fibrillation (other than full VVI pacing because of bradycardia)
4)severe systemic diasease ohter than heart diasease with life expectancy of less than one year.
5)schedule for or within 3 monthes after cardiac surgery, including open chast operation, coronary artery bypass graft, percuataneous coronary artery intervention
6)unable to folow up 1 year
7)inadequate to perticipate to the study from the medical point of view
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazutaka Aonuma
Organization University of Tsukuba, Graduate School of Comprehensive Human Sciences
Division name Cardiovascular Division
Zip code
Address 1-1-1 Tennodai, Tsukuba, Ibaraki
TEL 029-853-3142
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yoshihiro Seo
Organization University of Tsukuba, Graduate School of Comprehensive Human Sciences
Division name Cardiovascular Division
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute START study Steering Committee
Institute
Department

Funding Source
Organization Cardiovascular Division, University of Tsukuba
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
2010 Year 02 Month 01 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 Enrolling by invitation
Date of protocol fixation
2009 Year 08 Month 30 Day
Date of IRB
Anticipated trial start date
2009 Year 09 Month 01 Day
Last follow-up date
2012 Year 08 Month 01 Day
Date of closure to data entry
2012 Year 10 Month 01 Day
Date trial data considered complete
2012 Year 12 Month 01 Day
Date analysis concluded
2012 Year 12 Month 01 Day

Other
Other related information To evaluate whether the echocardiographic speckle tracking imaging can predict the responder for cardiac resynchronization therapy

Management information
Registered date
2010 Year 01 Month 12 Day
Last modified on
2010 Year 01 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003445

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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