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Cardiac Biomarker in Pediatric Heart Disease

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01834976
First Posted: April 18, 2013
Last Update Posted: December 29, 2015
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.
Information provided by (Responsible Party):
Tomoyuki Kanazawa, Okayama University
  Purpose
The purpose of this study is to investigate cardiac biomarker during perioperative management in pediatric cardiac surgery.

Condition
Congenital Heart Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Study of Cardiac Biomarker During Perioperative Management in Pediatric Heart Disease

Resource links provided by NLM:


Further study details as provided by Tomoyuki Kanazawa, Okayama University:

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

Biospecimen Retention:   Samples With DNA
serum,urine

Enrollment: 74
Study Start Date: November 2012
Study Completion Date: December 2014
Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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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)
  Contacts and Locations
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
  More Information

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 Submitted: April 15, 2013
First Posted: April 18, 2013
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