UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029834 |
|---|---|
| Receipt number | R000034081 |
| Scientific Title | Echocardiographic clinical stratification of pregnant women with dilated cardiomyopathy |
| Date of disclosure of the study information | 2017/11/06 |
| Last modified on | 2017/11/06 01:50:00 |
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Basic information
Public title
Echocardiographic clinical stratification of pregnant women with dilated cardiomyopathy
Acronym
Echocardiographic clinical stratification of pregnant women with dilated cardiomyopathy
Scientific Title
Echocardiographic clinical stratification of pregnant women with dilated cardiomyopathy
Scientific Title:Acronym
Echocardiographic clinical stratification of pregnant women with dilated cardiomyopathy
Region
| Japan |
Condition
Condition
Pregnancy complicated with dilated cardiomyopathy
Classification by specialty
| Cardiology | Obstetrics and Gynecology | Anesthesiology |
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To validate the echocardiographic clinical stratification to detect pregnant women who require intervention in delivery.
High risk group satisfies at least one of following criteria before 34 weeks of pregnancy.
1. Left ventricular end-diastolic diameter /Height is more than 37mm/m
2. Left ventricular end-systolic diameter/Height is more than 26mm/m
3. Ejection fraction is 35% or less
4. Relative wall thickness is less than 0.24
Relative wall thickness=2(Posterior wall thickness)/Left ventricular end-diastolic diameter
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
To compare the proportion of pregnant women who require intervention. We use chi-square test for primary outcome.
The criteria of intervention
1. Emergency cesarean section
2. Artificial preterm delivery for cardiac complications
3. Forced delivery for fetal distress syndrome
Key secondary outcomes
Kaplan-Meier Curve of event free 8-year survival after delivery.
The events satisfy at least one of following criteria
1. Death
2. Heart failure
3. Stroke
4. Cardiac surgery
5. Arrhythmia
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
Female
Key inclusion criteria
Pregnant women with dilated cardiomyopathy
Key exclusion criteria
Muscular dystrophy
Congental cardiac disease
Peripartum cardiomyopathy
Dilated phase of hypertrophic cardiomyopathy
Target sample size
26
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Makoto Sasaki |
Organization
National Cerebral and Cardiovascular Center
Division name
Department of Anesthesiology
Zip code
Address
5-7-1 Fujishirodai, Suita, Oosaka 565-8565, Japan
TEL
+81-6-6833-5004
Sasaki-receives@ncvc.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Makoto Sasaki |
Organization
National Cerebral and Cardiovascular Center
Division name
Department of Anesthesiology
Zip code
Address
5-7-1 Fujishirodai, Suita, Oosaka 565-8565, Japan
TEL
+81-6-6833-5004
Homepage URL
Sasaki-receives@ncvc.go.jp
Sponsor or person
Institute
National Cerebral and Cardiovascular Center
Institute
Department
Personal name
Funding Source
Organization
No
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
国立研究開発法人国立循環器病研究センター
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 11 | Month | 06 | 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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 11 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 11 | Month | 06 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective cohort Study
Pregnant women with dilated cardiomyopathy in National Cerebral and Cardiovascular Center since 1984.
Management information
Registered date
| 2017 | Year | 11 | Month | 06 | Day |
Last modified on
| 2017 | Year | 11 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034081
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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