UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034872 |
|---|---|
| Receipt number | R000039757 |
| Scientific Title | Effect of preoperative pulmonary hypertension on perioperative mortality among mitral stenosis patients undergoing mitral valve replacement |
| Date of disclosure of the study information | 2018/11/13 |
| Last modified on | 2020/09/25 21:00:12 |
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Basic information
Public title
Effect of preoperative pulmonary hypertension on perioperative mortality among mitral stenosis patients undergoing mitral valve replacement
Acronym
Effect of preoperative pulmonary hypertension on perioperative mortality among mitral stenosis patients undergoing mitral valve replacement
Scientific Title
Effect of preoperative pulmonary hypertension on perioperative mortality among mitral stenosis patients undergoing mitral valve replacement
Scientific Title:Acronym
Effect of preoperative pulmonary hypertension on perioperative mortality among mitral stenosis patients undergoing mitral valve replacement
Region
| Japan |
Condition
Condition
mitral stenosis
Classification by specialty
| Anesthesiology | Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The previous studies reported that PH had a negative effect on mortality in patients with mitral regurgitation, although not well known with mitral stenosis. The aim of our study is to clarify the impact of preoperative PH on outcome of patients with MS undergoing mitral valve replacement.
Basic objectives2
Others
Basic objectives -Others
This is a retrospective observational single-center study. Patients data will be collected from medical and anesthetic record. From January 2006 to March 2018, patients diagnosed as severe mitral stenosis and underwent mitral valve replacement at Jichi Medical University Hospital will be enrolled. Patients will be divided into two groups, PH group and non-PH group by the preoperative ratio of systolic pulmonary pressure and systolic systemic pressure as cut off value of 0.3. We compare primary endpoint between the two groups.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Operative mortality(death within 30 days after operation or in-hospital death.)
Long term mortality(period between operation and death)
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
| 40 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
patients with severe mitral stenosis (area of mitral valve <=1.0 cm2) who underwent mitral valve replacement
Key exclusion criteria
patients with mild or moderate mitral stenosis (area of mitral valve>1.0 cm2)
patients who underwent previous mitral valve replacement
urgent surgery
patients without cardiac catheterization report recorded
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenzaburou Sugimoto |
Organization
Jichi Medical University
Division name
Department of Anesthesiology and Critical Care Medicine
Zip code
Address
3311-1, Yakushiji, Shimotsuke-City, Tochigi 329-0498, Japan
TEL
0285-44-2111
r0923ks@jichi.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenzaburou Sugimoto |
Organization
Jichi Medical University
Division name
Department of Anesthesiology and Critical Care Medicine
Zip code
Address
3311-1, Yakushiji, Shimotsuke-City, Tochigi 329-0498, Japan
TEL
0285-44-2111
Homepage URL
r0923ks@jichi.ac.jp
Sponsor or person
Institute
Jichi Medical University
Institute
Department
Personal name
Funding Source
Organization
Jichi Medical University
Organization
Division
Category of Funding Organization
Other
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
| 2018 | Year | 11 | Month | 13 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
69
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
Completed
Date of protocol fixation
| 2018 | Year | 11 | Month | 13 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 13 | Day |
Anticipated trial start date
| 2018 | Year | 11 | Month | 13 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
| 2019 | Year | 04 | Month | 30 | Day |
Other
Other related information
no data
Management information
Registered date
| 2018 | Year | 11 | Month | 13 | Day |
Last modified on
| 2020 | Year | 09 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039757
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