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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034872
Receipt No. 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 2018/11/13

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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
Email 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
Email r0923ks@jichi.ac.jp

Sponsor
Institute Jichi Medical University
Institute
Department

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
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
2018 Year 11 Month 13 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 Preinitiation
Date of protocol fixation
2018 Year 11 Month 13 Day
Date of IRB
Anticipated trial start date
2018 Year 11 Month 13 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information no data

Management information
Registered date
2018 Year 11 Month 13 Day
Last modified on
2018 Year 11 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039757

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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