UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019921 |
|---|---|
| Receipt number | R000022999 |
| Scientific Title | The Predictive Value of Right Ventricular Function Measured by Magnetic Resonance Imaging for Exercise Capacity after Transcatheter Closure in Patients with Atrial Septal Defect: a prospective cohort study. |
| Date of disclosure of the study information | 2015/11/25 |
| Last modified on | 2016/11/25 14:25:18 |
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Basic information
Public title
The Predictive Value of Right Ventricular Function Measured by Magnetic Resonance Imaging for Exercise Capacity after Transcatheter Closure in Patients with Atrial Septal Defect: a prospective cohort study.
Acronym
The predictive value of RV function for exercise capacity after ASO in ASD
Scientific Title
The Predictive Value of Right Ventricular Function Measured by Magnetic Resonance Imaging for Exercise Capacity after Transcatheter Closure in Patients with Atrial Septal Defect: a prospective cohort study.
Scientific Title:Acronym
The predictive value of RV function for exercise capacity after ASO in ASD
Region
| Japan |
Condition
Condition
Atrial septal defect
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the predictive value of right ventricular function measured by magnetic resonance imaging for exercise capacity after transcatheter closure in patients with atrial septal defect.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The absolute change from pre to post-operative exercise capacity as measured by peak exercise oxygen consumption in CPX at a year after the closure.
Key secondary outcomes
Percent change of peak exercise oxygen consumption.
The absolute change from pre to post-operative exercise capacity measured by 6-minute walk distance or Specific Activity Scale.
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
Patients with atrial septal defect (secundum) who will receive transcatheter closure.
Key exclusion criteria
Patients without magnetic resonance imaging and cardio-pulmonary exercise testing before transcatheter closure.
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshihisa Anzai |
Organization
National Cerebral and Cardiovascular Center Hospital
Division name
Division of Cardiovascular Medicine
Zip code
Address
5-7-1 Fujishiro-dai, Suita, Osaka 565-8565 Japan
TEL
06-6833-5012
anzai@ncvc.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naotsugu Iwakami |
Organization
National Cerebral and Cardiovascular Center Hospital
Division name
Division of Cardiovascular Medicine
Zip code
Address
5-7-1 Fujishiro-dai, Suita, Osaka 565-8565 Japan
TEL
06-6833-5012
Homepage URL
naoi1115@ncvc.go.jp
Sponsor or person
Institute
National Cerebral and Cardiovascular Center Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
| 2015 | Year | 11 | Month | 25 | 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
| 2014 | Year | 06 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 06 | Month | 27 | Day |
Last follow-up date
| 2017 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
All the consecutive ASD patients aged 20 and over who are eligible for transcatheter closure in National Cerebral and Cardiovascular Center Hospital from June 2014 to June 2016 will be enrolled in this study.
Excluded patients are those who do not receive MRI or CPX before transcatheter closure for the reason of scheduling problems or technical issues such that patients can not pedal the machine, and that their intracardiac devices do not allow taking MRI.
Measurement
Pre and post-operative CPX, 6 minute walk distance, Specific Activity Scale, cardiac MRI, echocardiography, laboratory data.
Outcome
The absolute change from pre to post-operative exercise capacity as measured by peak exercise oxygen consumption in CPX at a year after the closure, related to the right ventricular function measured by magnetic resonance imaging.
Management information
Registered date
| 2015 | Year | 11 | Month | 25 | Day |
Last modified on
| 2016 | Year | 11 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022999
