UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003018 |
|---|---|
| Receipt number | 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 23:51:10 |
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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
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
Sponsor or person
Institute
START study Steering Committee
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003445
