Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613001038785
Ethics application status
Approved
Date submitted
16/09/2013
Date registered
18/09/2013
Date last updated
19/06/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Carotid Artery Calcification on Orthopantomograms.
Scientific title
In patients having panoramic dental radiographs, can the presence of carotid artery calcification predict clinically significant carotid stenosis?
Secondary ID [1] 283226 0
None
Universal Trial Number (UTN)
U1111-1148-1066
Trial acronym
The CACO Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
carotid artery calcification 290098 0
Condition category
Condition code
Cardiovascular 290475 290475 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
When dental x-rays are performed, there are many structures visible on the x-ray besides the teeth and jaws. One important structure that is sometimes seen is the carotid artery, which supplies blood to the brain. If this artery becomes calcified or “hardened”, it can been seen on a dental orthopantomogram (OPG). Hardening of the arteries can eventually cause these arteries to become blocked, which can lead to a stroke.

Some people will have warning signs before having a stroke, but many patients are unaware that they were at risk. We are interested to see if the finding of calcified arteries on routine dental x-rays is related to narrowing of these vessels that could potentially lead to stroke.

We have selected patients attending for dental x-rays. Half of the participants will have calcified carotid arteries on their OPG, and half will not have visible carotid artery calcification, to provide a comparison group. The presence or absence of calcification will be determined by the Dental Radiologist for the SA Dental Service.

We will ask all study participants to attend The Queen Elizabeth Hospital on a single occasion to undergo a carotid artery ultrasound study. There is no radiation involved with a carotid ultrasound study. The ultrasound is painless, and takes about 30 minutes to perform.

We expect it will take about 18 months to recruit people, and to perform all the ultrasound studies.
Intervention code [1] 287956 0
Diagnosis / Prognosis
Comparator / control treatment
N/A - This is a single group study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 290502 0
degree of carotid artery stenosis on ultrasound - this measured during the ultrasound scan by measuring the velocity changes in the artery which correlate with the degree of narrowing. The faster the blood flow, the narrower the vessel.
Timepoint [1] 290502 0
150 case-control age and sex-matched pairs. The degree of narrowing is assessed at ultrasound, then the degree of narrowing will be compared statistically to the presence (or absence) of calcification on OPG at the completion of the trial
Secondary outcome [1] 304644 0
determine the sensitivity and specificity of carotid artery calcification on OPG. This is assessed by noting the presence or absence of calcification on each OPG reviewed, and by using ultrasound as the "gold standard" for detecting calcification.
Timepoint [1] 304644 0
end of trial - when all participants have had an ultrasound

Eligibility
Key inclusion criteria
OPG that shows the carotid area
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
previous neck surgery

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)
patients with a visible carotid area are identified during routine reporting of dental x-rays. Those with carotid artery calcification are invited to participate. An age and sex-matched patient without calcification is then asked to participate to provide a control.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Statistician consulted. Advice given that a minimum of 110 patient in each of the case and control groups is needed to reach a precision of +/- 5% when determining a clinically significant narrowing

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/04/2012
Actual
19/03/2012
Date of last participant enrolment
Anticipated
31/12/2012
Actual
21/03/2014
Date of last data collection
Anticipated
Actual
21/03/2014
Sample size
Target
300
Accrual to date
Final
239
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 1526 0
The Queen Elizabeth Hospital - Woodville

Funding & Sponsors
Funding source category [1] 287974 0
Self funded/Unfunded
Name [1] 287974 0
Country [1] 287974 0
Australia
Primary sponsor type
Individual
Name
Dr Sarah Constantine
Address
Department of Radiology
The Queen Elizabeth Hospital
28 Woodville Road
Woodville South SA 5011
Country
Australia
Secondary sponsor category [1] 286695 0
None
Name [1] 286695 0
Address [1] 286695 0
Country [1] 286695 0
Other collaborator category [1] 277613 0
Individual
Name [1] 277613 0
Dr Denise Roach
Address [1] 277613 0
Department of Radiology
The Queen Elizabeth Hospital
28 Woodville Road
Woodville South SA 5011
Country [1] 277613 0
Australia
Other collaborator category [2] 277614 0
Individual
Name [2] 277614 0
Dr John Beltrame
Address [2] 277614 0
Department of Cardiology
The Queen Elizabeth Hospital
28 Woodville Road
Woodville South SA 5011
Country [2] 277614 0
Australia
Other collaborator category [3] 277615 0
Individual
Name [3] 277615 0
Dr Jim Jannes
Address [3] 277615 0
Department of Neurology
The Queen Elizabeth Hospital
28 Woodville Road
Woodville South SA 5011
Country [3] 277615 0
Australia
Other collaborator category [4] 277616 0
Individual
Name [4] 277616 0
Dr Sharon Liberali
Address [4] 277616 0
SA Dental Service
Adelaide Dental Hospital
Frome Road
Adelaide SA 5000
Country [4] 277616 0
Australia
Other collaborator category [5] 277617 0
Individual
Name [5] 277617 0
Dr Paul Sambrook
Address [5] 277617 0
SA Dental Service
Adelaide Dental Hospital
Frome Road
Adelaide SA 5000
Country [5] 277617 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289901 0
SA Department of Health Human Research Ethics Committee (EC00304)
Ethics committee address [1] 289901 0
Ethics committee country [1] 289901 0
Australia
Date submitted for ethics approval [1] 289901 0
Approval date [1] 289901 0
27/02/2012
Ethics approval number [1] 289901 0
EC00304

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 42990 0
Dr Sarah Constantine
Address 42990 0
Department of Radiology
The Queen Elizabeth Hospital
28 Woodville Road
Woodville South SA 5011
Country 42990 0
Australia
Phone 42990 0
+61 8 8222 6917
Fax 42990 0
Email 42990 0
[email protected]
Contact person for public queries
Name 42991 0
Sarah Constantine
Address 42991 0
Department of Radiology
The Queen Elizabeth Hospital
28 Woodville Road
Woodville South SA 5011
Country 42991 0
Australia
Phone 42991 0
+61 8 8222 6917
Fax 42991 0
Email 42991 0
[email protected]
Contact person for scientific queries
Name 42992 0
Sarah Constantine
Address 42992 0
Department of Radiology
The Queen Elizabeth Hospital
28 Woodville Road
Woodville South SA 5011
Country 42992 0
Australia
Phone 42992 0
+ 61 8 8222 6917
Fax 42992 0
Email 42992 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
EmbaseCarotid Artery Calcification on Orthopantomograms (CACO Study) - is it indicative of carotid stenosis?.2019https://dx.doi.org/10.1111/adj.12651
N.B. These documents automatically identified may not have been verified by the study sponsor.