Cardiac Biomarker in Pediatric Heart Disease

This study is currently recruiting participants. (see Contacts and Locations)
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
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, see Learn About Clinical Studies.

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 July 22, 2014