UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010381 |
|---|---|
| Receipt number | R000011964 |
| Scientific Title | Anatomy of coronary sinus visualized in the original post-processing images generated by the multidetector-row computed tomography scan before cardiac resynchronization therapy |
| Date of disclosure of the study information | 2013/04/02 |
| Last modified on | 2019/04/15 11:08:22 |
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Basic information
Public title
Anatomy of coronary sinus visualized in the original post-processing images generated by the multidetector-row computed tomography scan before cardiac resynchronization therapy
Acronym
Anatomy of Coronary Sinus in patients undergoing cardiac resynchronization therapy
Scientific Title
Anatomy of coronary sinus visualized in the original post-processing images generated by the multidetector-row computed tomography scan before cardiac resynchronization therapy
Scientific Title:Acronym
Anatomy of Coronary Sinus in patients undergoing cardiac resynchronization therapy
Region
| Japan |
Condition
Condition
Chronic heart failure with left ventricular systolic dysfunction and wide QRS complex
Classification by specialty
| Cardiology | Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We investigated the anatomy of coronary sinus visualized in the original post-processing images generated by the multidetector-row computed tomography scan before cardiac resynchronization therapy.
Basic objectives2
Others
Basic objectives -Others
We sought to evaluate whether the anatomy of coronary sinus was associated with underlying heart diseases and cardiac structures except for coronary sinus in patients undergoing cardiac resynchronization therapy.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Parameters of anatomy of coronary sinus and other cardiac structures
1. The diameter of coronary sinus ostium
2. The right atrial volume
3. The height of coronary sinus ostium above right atrial floor
4. The height of left atrial floor above right atrial floor
5. The tilt angle of proximal coronary sinus
6. The height of LA floor above coronary sinus ostium
7. The horizontal angle of proximal coronary sinus
8. The horizontal angle of the mitral annulus of left atrium
9. The location of coronary sinus ostium in anteroposterior view
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
Candidates for cardiac resynchronization therapy underwent multidetector-row computed tomography scan from 2008 to 2010
Key exclusion criteria
1) Patients who were judged to have no indication of cardiac resynchronization therapy
2) Patients who did not undergo multidetector-row computed tomography scan
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Toshiaki |
| Middle name | |
| Last name | Sato |
Organization
Kyorin University School of Medicine
Division name
Division of Cardiology, Second Department of Internal Medicine
Zip code
181-8611
Address
6-20-2 Shinkawa, Mitaka, Tokyo, 181-8611, Japan
TEL
+81-422-47-5511
toshiaki_sato@ks.kyorin-u.ac.jp
Public contact
Name of contact person
| 1st name | Toshiaki |
| Middle name | |
| Last name | Sato |
Organization
Kyorin University School of Medicine
Division name
Division of Cardiology
Zip code
181-8611
Address
6-20-2 Shinkawa, Mitaka, Tokyo, 181-8611, Japan
TEL
0422-47-5511
Homepage URL
toshiaki_sato@ks.kyorin-u.ac.jp
Sponsor or person
Institute
Department of Cardiology, Keio University, School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Keno university Cardiology
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
KEIO UNIVERSITY SCHOOL OF MEDICINE AN ETHICAL COMMITTEE
Address
Shinjyukuku shinanomachi 35
Tel
03-3353-1211
med-rinri-jimu@adst.keio.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
慶應義塾大学病院(東京都)
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 04 | Month | 02 | Day |
Related information
URL releasing protocol
https://upload.umin.ac.jp/cgi-open-bin/icdr/ctr_view.cgi?recptno=R000011964
Publication of results
Unpublished
Result
URL related to results and publications
https://upload.umin.ac.jp/cgi-open-bin/icdr/ctr_view.cgi?recptno=R000011964
Number of participants that the trial has enrolled
50
Results
CS anatomy was associated with atrial fibrillation, RA volume, and LA anatomy. Pre-procedural assessment of CS anatomy was necessary to implant devices for CRT.
Results date posted
| 2019 | Year | 04 | Month | 15 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2012 | Year | 03 | Month | 13 | Day |
Baseline Characteristics
Candidates for CRT underwent 64-slice multidetector-row computed tomography
Participant flow
retrospective registry
Adverse events
None
Outcome measures
Ct image measurements
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2008 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2012 | Year | 11 | Month | 10 | Day |
Anticipated trial start date
| 2013 | Year | 01 | Month | 04 | Day |
Last follow-up date
| 2013 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective study. The consecutive patients is enrolled into the study. We investigated the relationships among parameters below using post-processing images generated by the multidetector-row computed tomography scan.
1. The diameter of coronary sinus ostium
2. The right atrial volume
3. The height of coronary sinus ostium above right atrial floor
4. The height of left atrial floor above right atrial floor
5. The tilt angle of proximal coronary sinus
6. The height of LA floor above coronary sinus ostium
7. The horizontal angle of proximal coronary sinus
8. The horizontal angle of the mitral annulus of left atrium
9. The location of coronary sinus ostium in anteroposterior view
Management information
Registered date
| 2013 | Year | 04 | Month | 01 | Day |
Last modified on
| 2019 | Year | 04 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011964
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