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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000019921
Receipt No. 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

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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
Last 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
Email anzai@ncvc.go.jp

Public contact
1st 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
Email naoi1115@ncvc.go.jp

Sponsor
Institute National Cerebral and Cardiovascular Center Hospital
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022999

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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