UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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.
Title of the study (Brief title)	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	Toshihisa Anzai
Organization	National Cerebral and Cardiovascular Center Hospital
Division name	Division of Cardiovascular Medicine
Address	5-7-1 Fujishiro-dai, Suita, Osaka 565-8565 Japan
TEL	06-6833-5012
Email	anzai@ncvc.go.jp

Public contact
Name of contact person	Naotsugu Iwakami
Organization	National Cerebral and Cardiovascular Center Hospital
Division name	Division of Cardiovascular Medicine
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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2014 Year 06 Month 27 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000022999