Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000354088
Ethics application status
Approved
Date submitted
28/04/2010
Date registered
4/05/2010
Date last updated
12/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Prospective evaluation of an algorithm for coronary calcium estimation
Scientific title
Assessment of calcium score estimation from contrast cardiac computed tomography (CT) data in patients undergoing routine CT coronary angiography
Secondary ID [1] 251674 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary disease 257241 0
Condition category
Condition code
Cardiovascular 257378 257378 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Software quantification and algortihmic transformation of coronary calcium from a single standard contrast CT scan of duration 0.35 to 2 seconds.
Both Agatston calcium score and algorithmic caclium estimation will be performed blindly after completion of the CT scan.
Intervention code [1] 256358 0
Diagnosis / Prognosis
Comparator / control treatment
Coronary calcium score as assessed by voxel quantification using Agatston method scoring
Control group
Active

Outcomes
Primary outcome [1] 258293 0
Standard error of estimation of calcium score at high and low calcium score bands
Timepoint [1] 258293 0
After complete recruitment of 120 participants (estimated time 6 months)
Secondary outcome [1] 263994 0
Repeatability of the estimated calcium score as quantified by the intraclass correlation coefficient
Timepoint [1] 263994 0
After complete recruitment of 120 participants (estimated time 6 months)

Eligibility
Key inclusion criteria
Consecutive 120 patients undergoing CT coronary angiography and calcium scoring from study commencement.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unsuitable for calcium score evaluation: Coronary stents; Previous bypass surgery
Coronary occlusion detected at CT coronary angiography
CT coronary angiography unsuitable for calcium estimation: greater than 600 HU in asecneding or descending aorta; Greater than 35HU standard deviation in the ascending aorta at the level of the coronary sinsus

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All participants will be assessed by both Agatston calcium scoring and algorithmic calcium estimation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
All participants will be assessed by both methods.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
30/04/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 2842 0
2010

Funding & Sponsors
Funding source category [1] 256866 0
Self funded/Unfunded
Name [1] 256866 0
Country [1] 256866 0
Primary sponsor type
Individual
Name
Jane McCrohon
Address
Cardiology Department
St Vincents Public Hospital
Victoria Rd
Darlinghurst NSW 2010
Country
Australia
Secondary sponsor category [1] 256141 0
Individual
Name [1] 256141 0
James Otton
Address [1] 256141 0
Cardiology Department
St Vincents Public Hospital
Victoria Rd
Darlinghurst NSW 2010
Country [1] 256141 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258877 0
St Vincents Public Hospital Human Research Ethics Commitee (HREC)
Ethics committee address [1] 258877 0
St Vincents Public Hospital
Victoria Rd
Darlinghurst NSW 2010
Ethics committee country [1] 258877 0
Australia
Date submitted for ethics approval [1] 258877 0
21/04/2010
Approval date [1] 258877 0
23/04/2010
Ethics approval number [1] 258877 0

Summary
Brief summary
This trial is a prospective evaluation of a new method of diagnosing coronary calcium, using standard non contrast calcium score as the reference standard.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31090 0
Address 31090 0
Country 31090 0
Phone 31090 0
Fax 31090 0
Email 31090 0
Contact person for public queries
Name 14337 0
James Otton
Address 14337 0
Cardiology Department
St Vincents Public Hospital
Victoria Rd
Darlinghurst NSW 2010
Country 14337 0
Australia
Phone 14337 0
61 2 8382111
Fax 14337 0
61 2 83823871
Email 14337 0
[email protected]
Contact person for scientific queries
Name 5265 0
James Otton
Address 5265 0
Cardiology Department
St Vincents Public Hospital
Victoria Rd
Darlinghurst NSW 2010
Country 5265 0
Australia
Phone 5265 0
61 2 83821111
Fax 5265 0
61 2 83823871
Email 5265 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
SourceTitleYear of PublicationDOI
EmbaseA novel method of coronary calcium quantification allows the evaluation of both calcium score and coronary anatomy from a single contrast enhanced computed tomography scan.2011https://dx.doi.org/10.1016/S0735-1097%2811%2960885-1
Dimensions AICT Coronary Angiography Can Effectively Rule Out Significant Coronary Artery Disease in Patients Undergoing Cardiac Surgery2011https://doi.org/10.1016/j.hlc.2011.05.414
N.B. These documents automatically identified may not have been verified by the study sponsor.