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Trial registered on ANZCTR


Registration number
ACTRN12609000422224
Ethics application status
Not yet submitted
Date submitted
23/05/2009
Date registered
9/06/2009
Date last updated
9/06/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
Myocardial stress perfusion imaging with 320 slice multidetector computed tomography:- comparison with fractional flow reserve - pilot study
Scientific title
An evaluation of the accuracy of 320 slice multidetector computed tomography in detecting functionally significant coronary artery stenosis as compared against fractional flow reserve performed during coronary angiography.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stress myocardial perfusion imaging 4846 0
Condition category
Condition code
Cardiovascular 237192 237192 0 0
Coronary heart disease

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
We are observing the relationship between the transmural perfusion ratio (TPR) obtained from 320 slice multidetector computed tomography, which is an measure of myocardial ischemia upon stress against the gold standard of fractional flow reserve during coronary angiography. The observations are performed within one month of each other.
Intervention code [1] 236628 0
Not applicable
Comparator / control treatment
Myocardial stress ischemia detected on 320 slice multidetector computed tomography is compared against the gold standard of fractional flow reserve on coronary angiography. The latter is obtained from pressure readings taken from a specialised wire passed down the coronary artery. This reading is a one off reading, and will be taken within 1 month of the computed tomography scan.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 238007 0
To evaluate the accuracy of 320 slice multidetector computed tomography (320 MDCT) in detecting functionally significant coronary artery stenosis as compared against fractional flow reserve (FFR) performed during invasive coronary angiography.

Using images in the cardiac short axis with a 3mm slice thickness, the subendoardial and subepicardial borders are defined, and the transmural extent of perfusion abnormalities quantified using the transmural perfusion ratio (TPR). A ratio of <0.99 is considered abnormal. This ratio will be compared to FFR using sensitivity, specificity, negative predictive value and positive predictive value calculation on a vessel territory basis, using the 17 segment myocardial model, and on a per patient basis. Interobserver variability will be calculated.
Timepoint [1] 238007 0
One computed tomography scan and one fractional flow reserve is obtained, within a month of each other. Data will be obtained from each procedure, and outcomes used for comparison in bulk by blinded readers upon recruitment of a total of 20 cases.
Secondary outcome [1] 242146 0
Comparison of CT angiography (CTA) with invasive angiography will be performed. Independent observers will evaluate coronary artery stenoses (location, stenosis in percentage) on Computed tomographic coronary angiography images and on the invasive angiography.

For CTA, maximum intensity projection (MIP) and multiplanar reformat (MPR) and curved planar reformat images and dedicated software analysis will be used for evaluation of the stenosis severity and extent by two independent readers. For invasive angiography, two independent experienced interventional cardiologists will grade the stenosis, quantitative coronary angiography software will also be employed.

Statistical analysis will compare CTA with invasive coronary angiography. The diagnostic accuracy of CTA to detect significant stenosis (more than or equal to 50% and 70%) will be expressed as sensitivity, specificity, negative predictive value and positive predictive value.
Timepoint [1] 242146 0
One computed tomography scan and one fractional flow reserve is obtained, within a month of each other. Data will be obtained from each procedure, and outcomes used for comparison in bulk by blinded readers upon recruitment of a total of 20 cases.

Eligibility
Key inclusion criteria
Inclusion criteria:
1) Male greater than or equal to 40 years, Female greater than or equal to 50 years
2) Diagnosed coronary artery disease, with greater than or equal to 50% stenosis in one or more major
epicardial vessels
3) Able to give informed consent
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:
1) History of anaphylaxis to iodinated contrast media
2) Recent myocardial infarction (last 7 days) where culprit vessel may require FFR assessment.
3) Prior Q wave-myocardial infarction in the vessel territory interrogated by FFR
4) Patient with history of coronary artery bypass grafting
5) Cardiogenic shock
6) Advanced atrioventricular (AV) block – including 2nd degree AV block with mobitz type II and 3rd degree AV block)
7) Chronic atrial fibrillation
8) New York Heart Association (NYHA) class 3-4 congestive cardiac failure
9) Left ventricular hypertrophy by electrocardiographic (ECG) critieria
10) Hypertrophic cardiomyopathy
11) Severe asthma (requiring long term oral steroid therapy)
12) Pregnancy or with child bearing potential
13) Severe renal insufficiency as obtained from estimated glomerular filtration rate (eGFR <60ml/min/1.73m2)

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
1/07/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 5008 0
Hospital
Name [1] 5008 0
Monash Heart
Country [1] 5008 0
Australia
Primary sponsor type
Hospital
Name
Monash Heart
Address
Monash Medical Center
246 Clayton Road, Clayton 3168 VIC
Country
Australia
Secondary sponsor category [1] 4528 0
Hospital
Name [1] 4528 0
Monash Cardiovascular Research Centre
Address [1] 4528 0
246 Clayton Road, Clayton 3168 VIC
Country [1] 4528 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 7110 0
Ethics committee address [1] 7110 0
Ethics committee country [1] 7110 0
Date submitted for ethics approval [1] 7110 0
03/06/2009
Approval date [1] 7110 0
Ethics approval number [1] 7110 0

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

Contacts
Principal investigator
Name 29641 0
Address 29641 0
Country 29641 0
Phone 29641 0
Fax 29641 0
Email 29641 0
Contact person for public queries
Name 12888 0
Brian Ko
Address 12888 0
246 Clayton Road, Clayton 3168 VIC
Country 12888 0
Australia
Phone 12888 0
+ 613 95946666
Fax 12888 0
Email 12888 0
brian.ko@sesiahs.health.nsw.gov.au
Contact person for scientific queries
Name 3816 0
Brian Ko
Address 3816 0
246 Clayton Road, Clayton 3168 VIC
Country 3816 0
Australia
Phone 3816 0
+ 613 95946666
Fax 3816 0
Email 3816 0
brian.ko@sesiahs.health.nsw.gov.au

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.