- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02746029
Cardiac Murmurs in Children: Predictive Value of Cardiac Markers (CAMUS)
Heart murmurs are commonly discovered in young children during clinical encounters in general practice. Heart murmurs might signal a structural cardiac disease that need to be treated, such as atrial septal defect. Thus, children with heart murmurs are routinely referred to comprehensive cardiac examination at a paediatric hospital department featuring echocardiography ('gold standard'). However, the great majority of such murmurs are innocent or physiological; ie., they do not represent a cardiac disorder. The prevalence of such innocent murmurs during routine random auscultation is estimated at 30 %.
It would be advantageous if patients with a heart disease to a greater extent could be identified at the general practitioners' office:
- Healthy children would not be exposed to comprehensive cardiac examination
- The burden on the family would subside.
- Scarce medical resources in highly specialized departments would be better allocated, to the benefit of patients with real heart disease.
The primary aim of this study is to establish the predictive value of cardiac markers in children with heart murmurs. Secondary aims are a) To do a pilot study of pediatric cardiac ultrasound examination in general practice; b) To establish age-adjusted reference range for cardiac markers in children, and c) To explore aspects of cardiovascular physiology in children.
The investigators will include a total of 500 children aged 4 weeks to 10 years who is consecutively referred to the Dept. of Paediatrics, Akershus University Hospital, for assessment of heart murmurs. All participants will be subjected to clinical examination, symptom assessment, pulse oximetry, blood sampling (for troponin T, proBNP and other biomarkers), ECG recording, and echocardiography. A randomized subgroup of children will also undergo echocardiography performed by a general practitioner who has not received formal training in pediatric cardiology. The value of possible predictors will be assessed through the construction of Receiver Operating Characteristics (ROC) curves, and calculation of negative predictive value.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
Akershus
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Lørenskog, Akershus, Norway, N-1478
- Dept. of Pediatrics, Akershus University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Spontaneously discovered heart murmur at general practitioner's office
Exclusion Criteria:
- Known cardiac disease
- Other chronic or acute disorder
- Medications
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Children with cardiac murmur
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of patients with any congenital heart disease as assessed by echocardiography
Time Frame: 1 day
|
1 day
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Vegard Wyller, University Hospital, Akershus
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CAMUS
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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