We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Cardiac Biomarker in Pediatric Heart Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01834976
Recruitment Status : Completed
First Posted : April 18, 2013
Last Update Posted : December 29, 2015
Sponsor:
Information provided by (Responsible Party):
Tomoyuki Kanazawa, Okayama University

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

Condition or disease
Congenital Heart Disease

Study Type : Observational
Actual Enrollment : 74 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Study of Cardiac Biomarker During Perioperative Management in Pediatric Heart Disease
Study Start Date : November 2012
Primary Completion Date : November 2014
Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Diseases
U.S. FDA Resources




Primary Outcome Measures :
  1. serious adverse events [ Time Frame: one month ]

Biospecimen Retention:   Samples With DNA
serum,urine


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
pediatric patients who receive surgery for congenital heart disease under 18 years old
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01834976


Locations
Japan
Okayama University Hospital
Okayama, Japan, 7008558
Sponsors and Collaborators
Okayama University

Responsible Party: Tomoyuki Kanazawa, Pediatric cardiac surgery investigators, Okayama University
ClinicalTrials.gov Identifier: NCT01834976     History of Changes
Other Study ID Numbers: pchd biomarker in okayama
First Posted: April 18, 2013    Key Record Dates
Last Update Posted: December 29, 2015
Last Verified: December 2015

Keywords provided by Tomoyuki Kanazawa, Okayama University:
cardiac biomarker
congenital heart disease
surgery

Additional relevant MeSH terms:
Heart Diseases
Heart Defects, Congenital
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities