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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

Tracking Information
First Submitted Date April 15, 2013
First Posted Date April 18, 2013
Last Update Posted Date December 29, 2015
Study Start Date November 2012
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 17, 2013)
serious adverse events [ Time Frame: one month ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01834976 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Cardiac Biomarker in Pediatric Heart Disease
Official Title Observational Study of Cardiac Biomarker During Perioperative Management in Pediatric Heart Disease
Brief Summary The purpose of this study is to investigate cardiac biomarker during perioperative management in pediatric cardiac surgery.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
serum,urine
Sampling Method Non-Probability Sample
Study Population pediatric patients who receive surgery for congenital heart disease under 18 years old
Condition Congenital Heart Disease
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: December 27, 2015)
74
Original Estimated Enrollment
 (submitted: April 17, 2013)
150
Actual Study Completion Date December 2014
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
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)
Sex/Gender
Sexes Eligible for Study: All
Ages up to 18 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Japan
Removed Location Countries  
 
Administrative Information
NCT Number NCT01834976
Other Study ID Numbers pchd biomarker in okayama
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Tomoyuki Kanazawa, Okayama University
Study Sponsor Okayama University
Collaborators Not Provided
Investigators Not Provided
PRS Account Okayama University
Verification Date December 2015