Cardiac Biomarker in Pediatric Heart Disease | NCT01834976

Studies
Cardiac Biomarker in Pediatric Heart Disease

NCT01834976

Sponsor

Okayama University

Status

Completed

Last Update Posted

Dec 29, 2015Estimated

Enrollment

74Actual

Phase

Not provided

Conditions

Congenital Heart Disease

Interventions

Not provided

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2012

Primary Completion Date

Nov 2014Actual

Completion Date

Dec 2014Actual

First Submitted Date

Apr 15, 2013

First Submission Date that Met QC Criteria

Apr 17, 2013

First Posted Date

Apr 18, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 27, 2015

Last Update Posted Date

Dec 29, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Tomoyuki Kanazawa, Pediatric cardiac surgery investigators, Okayama UniversityPrincipal Investigator

Lead Sponsor

Okayama UniversityOTHER

Collaborators

Not provided

Description Module

Brief Summary

The purpose of this study is to investigate cardiac biomarker during perioperative management in pediatric cardiac surgery.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

74Actual

Measure	Description	Time Frame
serious adverse events		one month

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

children who receive surgery for congenital heart disease
require cardiopulmonary bypass for surgery
under 18 years old

Exclusion Criteria:

simple congenital heart disease (atrial septal defect, ventricle septal defect, patent ductus arteriosus)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

pediatric patients who receive surgery for congenital heart disease under 18 years old

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Okayama University Hospital		Okayama	Okayama-ken	7008558	Japan

Condition Browse Module

MeSH Terms

ID	Term
D006330	Heart Defects, Congenital

Ancestor Terms

ID	Term
D018376	Cardiovascular Abnormalities
D002318	Cardiovascular Diseases
D006331	Heart Diseases
D000013	Congenital Abnormalities

Browse Leaves

Not provided

Browse Branches

Not provided