Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000206123
Ethics application status
Approved
Date submitted
30/01/2019
Date registered
12/02/2019
Date last updated
12/02/2019
Date data sharing statement initially provided
12/02/2019
Date results information initially provided
12/02/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Measurement of severity of aortic stenosis in patients using aortic acceleration time
Scientific title
Aortic acceleration time in patients with aortic stenosis under general anaesthesia
Secondary ID [1] 297190 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Aortic stenosis 311242 0
Condition category
Condition code
Cardiovascular 309862 309862 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
1
Target follow-up type
Hours
Description of intervention(s) / exposure
Retrospective analysis of the continuous wave Doppler signal in patients with aortic stenosis having cardiac surgery, including the aortic acceleration time from our echocardiography database Prosolve. No input from patients is required including repeat scanning, repeat investigations or consent to access records.
Intervention code [1] 313446 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 318806 0
Aortic acceleration time as assessed by audit of Prosolve database
Timepoint [1] 318806 0
Retrospective analysis of echocardiograms in patient with aortic stenosis
Secondary outcome [1] 366116 0
Severity of aortic stenosis using AAT measured with echocardiography
Timepoint [1] 366116 0
Retrospective analysis of hospital data

Eligibility
Key inclusion criteria
Patients with aortic stenosis having general anaesthesia for an aortic valve replacement where an intraoperative transesophageal echocardiogram was performed
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Nil

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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
4/12/2015
Date of last participant enrolment
Anticipated
Actual
6/02/2019
Date of last data collection
Anticipated
Actual
6/02/2019
Sample size
Target
350
Accrual to date
Final
300
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 301743 0
Hospital
Name [1] 301743 0
St. Vincent's Hospital, Melbourne
Country [1] 301743 0
Australia
Primary sponsor type
Individual
Name
Brian Cowie
Address
Department of Anaesthesia
St. Vincent's Hospital, Melbourne
Fitzroy 3065
Victoria
Australia
Country
Australia
Secondary sponsor category [1] 301485 0
None
Name [1] 301485 0
Address [1] 301485 0
Country [1] 301485 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302466 0
St. Vincent's Hospital, Melbourne HREC
Ethics committee address [1] 302466 0
HREC
St. Vincent's Hospital, Melbourne
45 Victoria Parade
Fitzroy 3065
Victoria, Australia
Ethics committee country [1] 302466 0
Australia
Date submitted for ethics approval [1] 302466 0
Approval date [1] 302466 0
04/12/2015
Ethics approval number [1] 302466 0
QA 109/15

Summary
Brief summary
Aortic valve replacement for aortic stenosis is a common procedure. Preoperative transthoracic echocardiography (TTE) and intraoperative transesophageal echocardiography (TOE) are commonly used to guide surgical decision making in the management of aortic stenosis. The maximum aortic valve jet velocity, mean gradient and aortic valve area and aortic acceleration time are normally used to grade the severity of aortic stenosis.
The aim of this study was to assess the validity of AAT and the ratio of AAT/ET as a reliable marker of the severity of aortic stenosis using intraoperative transesophageal echocardiography and to compare these findings to those obtained using preoperative transthoracic echocardiography in patients undergoing aortic valve replacement.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 90318 0
Dr Brian Cowie
Address 90318 0
Department of Anaesthesia
St. Vincent's Hospital, Melbourne
41 Victoria Parade
Fitzroy 3065
Victoria
Australia
Country 90318 0
Australia
Phone 90318 0
+613 92882211
Fax 90318 0
Email 90318 0
[email protected]
Contact person for public queries
Name 90319 0
Dr Brian Cowie
Address 90319 0
Department of Anaesthesia
St. Vincent's Hospital, Melbourne
41 Victoria Parade
Fitzroy 3065
Victoria
Australia
Country 90319 0
Australia
Phone 90319 0
+613 92882211
Fax 90319 0
Email 90319 0
[email protected]
Contact person for scientific queries
Name 90320 0
Dr Brian Cowie
Address 90320 0
Department of Anaesthesia
St. Vincent's Hospital, Melbourne
41 Victoria Parade
Fitzroy 3065
Victoria
Australia
Country 90320 0
Australia
Phone 90320 0
+613 92882211
Fax 90320 0
Email 90320 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
1244    



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseAortic Acceleration Time and the Intraoperative Assessment of Aortic Stenosis.2021https://dx.doi.org/10.1053/j.jvca.2020.10.048
N.B. These documents automatically identified may not have been verified by the study sponsor.