Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001478808p
Ethics application status
Submitted, not yet approved
Date submitted
9/09/2021
Date registered
28/10/2021
Date last updated
28/10/2021
Date data sharing statement initially provided
28/10/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The utility of coronary artery calcium scoring in myocardial perfusion scan
Scientific title
Correlation of coronary artery calcium scores on myocardial perfusion scans and computed tomography coronary angiography in patients with low to intermediate risk cardiac chest pain.
Secondary ID [1] 305281 0
Nil Known
Universal Trial Number (UTN)
U1111-1269-3705
Trial acronym
CAMPS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ischaemic Heart Disease 323580 0
Chest Pain 323581 0
Condition category
Condition code
Cardiovascular 321129 321129 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
To assess the correlation between the coronary artery calcium score on myocardial perfusion scans versus on dedicated computed tomography coronary angiography, participants who have had myocardial perfusion imaging will be required to subsequently have a dedicated computed tomography coronary angiography scan for coronary artery calcium scoring.

The additional computed tomography coronary angiography has additional radiation exposure. The radiation exposure involved in myocardial perfusion imaging has been found to be between 10-20 millisieverts, whereas the radiation exposure for a dedicated coronary artery calcium score CT is 1 millisievert. The average Australian background radiation exposure per year is 1.5-2milliseverts.

Participants will undergo the dedicated computed tomography coronary angiography within 2 weeks of having their myocardial perfusion scan. The computed tomography coronary angiography will be undertaken at the same centre (Tamworth Rural Referral Hospital), and take approximately 30 minutes. The scan will be completed by a trained diagnostic radiographer at the centre. The computed tomography coronary angiography includes the administration of a contrast agent Iohexol (Omnipaque Trade Name) via intravenous infusion. The administered dose will be between 0 to 100mls and be determined by the diagnostic radiographer at the time of the scan and based on patients body habitus, to ensure an optimal scan. Participants may also require the administration of a heart rate controlling medication, metoprolol, to achieve an optimal heart rate of approximately 60 beats per minute for the scan.

The computed tomography coronary angiography and myocardial perfusion computed tomography scans will be assessed at the same centre by the researchers to determine whether there is a correlation between the two coronary artery calcium scores.

Patients who do not undergo the dedicated computed tomography coronary angiography will be excluded from the study. This will be determined by the absence of a dedicated computed tomography coronary angiography at the time of conducting the coronary artery calcium scores on the respective images.

All participants will undergo the same intervention. The amount of the contrast agent, the requirement for metoprolol for rate control and the dose of radiation from the computed tomography scan will vary between patients. Each of these will be noted in the data collection and in the reporting of the study.
Intervention code [1] 321686 0
Diagnosis / Prognosis
Intervention code [2] 321687 0
Early detection / Screening
Comparator / control treatment
Each participants will have the myocardial perfusion scan as their standard investigation for underlying coronary artery disease. All participants will the subsequently have the computed tomography coronary angiography. This will enable the calculation of the coronary artery calcium score in both image modalities to assess the correlation between imaging modalities.
Control group
Active

Outcomes
Primary outcome [1] 328908 0
The validity of the coronary artery calcium score on myocardial perfusion scans, assessing that it correlates with the coronary artery calcium score on computed tomography coronary angiography. This will be assessed for accuracy and sensitivity.
Timepoint [1] 328908 0
At time of reporting of the coronary artery calcium score on both the myocardial perfusion scan computed tomography and on the computed tomography coronary angiography, approximately 2-4 weeks after patients undergo both scans.
Secondary outcome [1] 401781 0
Nil
Timepoint [1] 401781 0
Nil

Eligibility
Key inclusion criteria
The inclusion criteria will include any patient over the age of 18 years of age, who has presented with symptoms of cardiac ischaemia that has been deemed to be low to intermediate risk.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The exclusion criteria for this phase is any patient with known coronary artery disease defined as previous cardiac surgical intervention, percutaneous coronary intervention, any patient with a congenital cardiac condition, recent myocardial infarction defined by changes to electrocardiography and cardiac biomarkers, myocarditis and/or moderate to severe valve calcification which would impair coronary artery calcium scoring, as well as any condition that would prevent patients undergoing a myocardial perfusion or computed tomography.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Correlation of coronary artery calcium score on myocardial perfusion scans and on computed tomography coronary angiography.
- Aim to enrol the least amount of patients to show correlation
- Aim to enrol 10-25 patients with the ability to increase to 50 if increased correlation coefficient required.
- Data analysis will be conducted using SPSS (TM) to assess the correlation coefficient.
- Demographic data of the included patients will be also assessed using means.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2021
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
25
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 20505 0
Tamworth Rural Referral Hospital - Tamworth
Recruitment postcode(s) [1] 35282 0
2340 - Tamworth

Funding & Sponsors
Funding source category [1] 309653 0
Hospital
Name [1] 309653 0
Tamworth Rural Referral Hospital
Country [1] 309653 0
Australia
Primary sponsor type
Individual
Name
Shanathan Sritharan
Address
Tamworth Rural Referral Hospital
Dean Street
North Tamworth 2340
NSW
Australia
Country
Australia
Secondary sponsor category [1] 310669 0
None
Name [1] 310669 0
Address [1] 310669 0
Country [1] 310669 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 309420 0
Hunter New England Health Human Research Ethic Committee
Ethics committee address [1] 309420 0
John Hunter Hospital
Look Out Road
New Lambton, 2305
NSW
Ethics committee country [1] 309420 0
Australia
Date submitted for ethics approval [1] 309420 0
13/09/2021
Approval date [1] 309420 0
Ethics approval number [1] 309420 0

Summary
Brief summary
Nuclear medicine myocardial perfusion imaging is currently indicated in patients with symptoms of cardiac ischaemia, who have either failed a stress echocardiogram, are unable to exercise to the extent required to provide an adequate stress echocardiogram or have a body habitus or other physical condition that would prevent an adequate stress echocardiogram.

A nuclear medicine myocardial perfusion scan consists of an intravenously administered radioisotope, which can then be assessed with either single photon emission computer tomography (SPECT) or positron emission tomography (PET). This allows the assessment of the underlying myocardium and the underlying coronary arteries.

More recently coronary artery calcium (CAC) scoring has been developed to assess patients without known coronary artery disease who present with symptoms of acute ischaemia and are of low or intermediate risk, without electrocardiograph changes or elevation in cardiac biomarkers.

As both investigations utilise computed tomography (CT), our aim is to assess the value of coronary artery calcium scoring on nuclear medicine myocardial perfusion scans, in order to improve the diagnosis and outcomes in patients with low to intermediate risk cardiac ischaemia.

Currently there is no research available on the utility of coronary artery calcium scoring in myocardial perfusion scans. The investigators aim to show a correlation of the coronary artery calcium score between the computed tomography conducted for myocardial perfusion imaging and dedicated computed tomography imaging. This will then allow the assessment of the coronary artery calcium score retrospectively in participants who underwent myocardial perfusion imaging to assess the change in predefined outcomes when utilising the additional measure.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 114098 0
Dr Shanathan Sritharan
Address 114098 0
Tamworth Rural Referral Hospital
Dean Street
North Tamworth, 2340
NSW
Country 114098 0
Australia
Phone 114098 0
+61 0267677700
Fax 114098 0
Email 114098 0
[email protected]
Contact person for public queries
Name 114099 0
Dr Shanathan Sritharan
Address 114099 0
Tamworth Rural Referral Hospital
Dean Street
North Tamworth, 2340
NSW
Country 114099 0
Australia
Phone 114099 0
+61 0267677700
Fax 114099 0
Email 114099 0
[email protected]
Contact person for scientific queries
Name 114100 0
Dr Shanathan Sritharan
Address 114100 0
Tamworth Rural Referral Hospital
Dean Street
North Tamworth, 2340
NSW
Country 114100 0
Australia
Phone 114100 0
+61 0267677700
Fax 114100 0
Email 114100 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?

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.