UMIN-CTR Clinical Trial

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

Atrial septal defect

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO

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

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.

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

National Cerebral and Cardiovascular Center Hospital

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2015

Year

11

Month

25

Day

URL releasing protocol

Publication of results

Unpublished

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

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 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.

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