Congenital Heart DiseaseNCT01834976
Cardiac Biomarker in Pediatric Heart Disease
An observational study of Congenital Heart Disease, run by Okayama University at 1 site in Japan.
Trial summary
The purpose of this study is to investigate cardiac biomarker during perioperative management in pediatric cardiac surgery. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Congenital Heart Disease
- How many people
- 74 participants
- Where
- 1 siteJapan
- Study dates
- Nov 2012to Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: pediatric patients who receive surgery for congenital heart disease under 18 years old
Who may be able to join
- children who receive surgery for congenital heart disease
- require cardiopulmonary bypass for surgery
- under 18 years old
Who cannot join
- simple congenital heart disease (atrial septal defect, ventricle septal defect, patent ductus arteriosus)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Observational Study of Cardiac Biomarker During Perioperative Management in Pediatric Heart Disease
The purpose of this study is to investigate cardiac biomarker during perioperative management in pediatric cardiac surgery.
- Conditions
- Congenital Heart Disease
- Keywords
- cardiac biomarker, congenital heart disease, surgery
- Medical subject headings
- Heart Defects, Congenital
What is being measured
The primary outcome is the main question the study is designed to answer.
serious adverse events
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2013 (estimated)
- Study startNov 2012
- Primary completionNov 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Okayama University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tomoyuki Kanazawa, Okayama University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01834976
- Sponsor's protocol ID
- pchd biomarker in okayama
- Status last verified
- Dec 2015
- First submitted
- 15 Apr 2013
- Last updated
- 29 Dec 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of Cardiac Biomarker During Perioperative Management in Pediatric Heart Disease
- ClinicalTrials.gov ID
- NCT01834976
- Acronym / sponsor ID
- pchd biomarker in okayama
- Conditions
- Congenital Heart Disease
- Keywords
- cardiac biomarker, congenital heart disease, surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Okayama UniversityUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Nov 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 18 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate cardiac biomarker during perioperative management in pediatric cardiac surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- pediatric patients who receive surgery for congenital heart disease under 18 years old
Key inclusion criteria (3 listed)
- children who receive surgery for congenital heart disease
- require cardiopulmonary bypass for surgery
- under 18 years old
Key exclusion criteria (1 listed)
- simple congenital heart disease (atrial septal defect, ventricle septal defect, patent ductus arteriosus)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
serious adverse events
Time frame: one month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Heart Disease, run by Okayama University at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serious adverse events (time frame: one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2015.