Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000442505
Ethics application status
Not yet submitted
Date submitted
9/10/2006
Date registered
16/10/2006
Date last updated
16/10/2006
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of 3 dimensional echocardiography’s accuracy to cardiac MRI scans.
Scientific title
Comparison of left and right ventricular volume measurements with Real-time 3-dimensional echocardiography and cardiac magnetic resonance imaging in congenital heart disease
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Congenital heart disease, subjects with a cardiac defect that they have been born with. 1414 0
Condition category
Condition code
Cardiovascular 1511 1511 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Real time 3 dimensional echo (RT3DE) data to be collected from subjects with congenital heart disease for measurement of Right ventricle (RV)/ Left ventricle (LV) parameters and compared with cardiac magnetic resonance imaging (MRI) data of the same parameters. This would take 1 year.
Intervention code [1] 1394 0
Diagnosis / Prognosis
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 2087 0
Bland Altman analysis of comparitive data for both LV and RV real time 3 dimensional echocardiography datasets vs cardiac MRI.
Timepoint [1] 2087 0
Dataset will be collected at the time of their cardiac MRI and compared. No other timepoints for remeasuring.
Secondary outcome [1] 3603 0
Bland altman analysis of semi automated border detection technology for RT3DE in congenital heart disease vs cardiac MRI.
Timepoint [1] 3603 0
Datasets analysed will be the same as those collected at the time of their cardiac MRI. No other time points for remeasuring.

Eligibility
Key inclusion criteria
Patient population are patients on waiting list for cardiac MRI for congenital heart defect and NOT requiring general anaesthesia.Inclusion criteria:1) have congenital heart disease2) patient not require general anaesthesia for scan.
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) significant alteration of clinical status (alteration in preload or afterload conditions) between MRI and RT3DE scan. ie received IV fluids, taken diuretics2)Both scan must occur within 3 hours of each other.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 406 0
New Zealand
State/province [1] 406 0

Funding & Sponsors
Funding source category [1] 1646 0
Hospital
Name [1] 1646 0
Starship hospital
Country [1] 1646 0
New Zealand
Primary sponsor type
Hospital
Name
Paediatric Congenital Cardiac Services (PCCS), Starship hospital
Address
Country
New Zealand
Secondary sponsor category [1] 1455 0
None
Name [1] 1455 0
nil
Address [1] 1455 0
Country [1] 1455 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 3095 0
Northen X region ethics committee, Starship hospital
Ethics committee address [1] 3095 0
Ethics committee country [1] 3095 0
New Zealand
Date submitted for ethics approval [1] 3095 0
Approval date [1] 3095 0
Ethics approval number [1] 3095 0

Summary
Brief summary
Study will use real time 3 dimensional echocardiography (RT3DE) to determine right and left ventricular volumes, ejection fraction (EF) and mass on patients with congenital heart disease under going cardiac MRI. This is a validation study of RT3DE, a new modality of cardiac imaging for clinical use in congenital heart disease.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27621 0
Address 27621 0
Country 27621 0
Phone 27621 0
Fax 27621 0
Email 27621 0
Contact person for public queries
Name 10583 0
Dr Nee Scze Khoo
Address 10583 0
Paediatric Congenital Cardiac Services
Starship Children's Hospital
Grafton
Auckland
Country 10583 0
New Zealand
Phone 10583 0
+64 9 3074949 page 5193
Fax 10583 0
Email 10583 0
[email protected]
Contact person for scientific queries
Name 1511 0
Dr Nee Scze Khoo
Address 1511 0
Paediatric Congenital Cardiac Services
Starship Children's Hospital
Grafton
Auckland
Country 1511 0
New Zealand
Phone 1511 0
+64 9 3074949 page 5193
Fax 1511 0
Email 1511 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.