Cardiac Biomarker in Pediatric Heart Disease

This study is currently recruiting participants.
Verified April 2013 by Okayama University
Sponsor:
Information provided by (Responsible Party):
Tomoyuki Kanazawa, Okayama University
ClinicalTrials.gov Identifier:
NCT01834976
First received: April 15, 2013
Last updated: April 17, 2013
Last verified: April 2013
  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 Okayama University:

Primary Outcome Measures:
  • serious adverse events [ Time Frame: one month ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   Samples With DNA

serum,urine


Estimated Enrollment: 150
Study Start Date: November 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01834976

Contacts
Contact: TOMOYUKI KANAZAWA +81862357778 tyskanazawa@gmail.com
Contact: MORITOKI EGI +81862357778 moriori@tg8.so-net.ne.jp

Locations
Japan
Okayama University Hospital Recruiting
Okayama, Japan, 7008558
Contact: TOMOYUKI KANAZAWA    +81862357778    tyskanazawa@gmail.com   
Contact: MORITOKI EGI    +81862357778    moriori@tg8.so-net.ne.jp   
Sponsors and Collaborators
Okayama University
  More Information

No publications provided

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
Study First Received: April 15, 2013
Last Updated: April 17, 2013
Health Authority: Japan: Ministry of Education, Culture, Sports, Science and Technology

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

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

ClinicalTrials.gov processed this record on April 22, 2014