Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001239358
Ethics application status
Approved
Date submitted
22/08/2017
Date registered
24/08/2017
Date last updated
4/03/2019
Date data sharing statement initially provided
4/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Non-invasive validation of shear stress measurements in patients with coronary artery disease
Scientific title
Assessment of the diagnostic accuracy for coronary endothelial shear stress values derived from computed tomography coronary angiography
Secondary ID [1] 292691 0
Nil known.
Universal Trial Number (UTN)
Trial acronym
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
coronary artery disease 304446 0
Condition category
Condition code
Cardiovascular 303776 303776 0 0
Coronary heart disease

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Patients with non-obstructive atherosclerotic plaque at coronary angiography will undergo both invasive (the gold-standard) and non-invasive assessment of endothelial shear stress (ESS). Non-invasive assessment of ESS will be performed using CT coronary angiography (CTCA) within one month of the invasive assessment. This will be performed on a 320-slice CT scanner following administration of medication (e.g. beta-blockers) to control heart rate, in accordance with published guidelines. Image acquisition will require injection of contrast agent and participants to lie flat for around 15mins. Following CTCA acquisition, 3D reconstruction of the coronary arteries will be performed with this model used as basis of computational fluid dynamic simulations. ESS will be calculated throughout the arterial tree and these values compared with that derived invasively. Providers and readers of the index tests will have full access to clinical information and previous test results. The results of the research CTCA will be available to the treating physician.
Intervention code [1] 298932 0
Diagnosis / Prognosis
Comparator / control treatment
Gold-standard ESS measurements will be performed through computational fluid dynamic simulations based on a 3D reconstructed model of the coronary artery created from selective angiography and intravascular ultrasound.
Control group
Active

Outcomes
Primary outcome [1] 303142 0
The primary aim of this study is to assess the sensitivity of CTCA to identify low (<10 dynes/cm2) ESS arterial segments, using intravascular ultrasound (IVUS)-derived measures as gold-standard.
Timepoint [1] 303142 0
Baseline
Secondary outcome [1] 338023 0
The secondary aim of this study is to assess whether there is a correlation between CTCA- and IVUS-defined ESS measurements.
Timepoint [1] 338023 0
Baseline

Eligibility
Key inclusion criteria
1) Age greater or equal to 18 years of age.
2) Able to provide informed consent
3) Undergoing (or due to undergo) invasive coronary angiography for clinical reasons
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Chronic renal failure with eGFR < 30 ml/min
2) Previous coronary artery bypass surgery
3) Left ventricular ejective fraction < 50% or known regional wall motion abnormality on echocardiogram
4) Atrial fibrillation
6) Moderate or severe aortic stenosis or left ventricular outflow tract gradient
7) Decompensated heart failure
8) Severe asthma or resting bradycardia precluding use of adenosine
9) Unfavourable coronary anatomy that would prohibit safe intracoronary imaging
10) Women of childbearing age

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
The primary aim of this study is to assess the sensitivity of CTCA to identify low ESS arterial segments, using IVUS-derived measures as gold-standard. For this study, the pre-determined value for optimal sensitivity is 90%, with the maximum marginal error of the estimate not exceeding 7% using 95% confidence intervals.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/09/2017
Actual
5/09/2017
Date of last participant enrolment
Anticipated
31/05/2019
Actual
Date of last data collection
Anticipated
31/05/2019
Actual
Sample size
Target
34
Accrual to date
21
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 8844 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment postcode(s) [1] 16979 0
3168 - Clayton

Funding & Sponsors
Funding source category [1] 297333 0
University
Name [1] 297333 0
Monash University
Country [1] 297333 0
Australia
Primary sponsor type
Hospital
Name
MonashHeart
Address
MonashHeart
Monash Health
Monash Medical Centre
246 Clayton Road
Clayton
Victoria
3168
Country
Australia
Secondary sponsor category [1] 296306 0
None
Name [1] 296306 0
Address [1] 296306 0
Country [1] 296306 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298434 0
Monash Health Ethics Committee
Ethics committee address [1] 298434 0
Monash Health
Monash Medical Centre
246 Clayton Road
Clayton
Victoria
3168
Ethics committee country [1] 298434 0
Australia
Date submitted for ethics approval [1] 298434 0
10/02/2017
Approval date [1] 298434 0
29/05/2017
Ethics approval number [1] 298434 0
HREC/17/MonH/57

Summary
Brief summary
Cardiovascular disease remains a leading cause of death and disability in our community, with atherosclerosis being the major disease process underlying the majority of heart attacks. Atherosclerosis is a disease in which plaques made up of fat (cholesterol) builds up in the wall of an artery. As plaque builds up it can narrow the coronary artery and reduce blood flow to your heart muscle. There is also a risk that the plaque may rupture causing a sudden blockage of the artery. This can cause a heart attack, which results in permanent damage to heart muscle. However, there is little understanding of how plaques grow in the arteries and what makes certain plaques at high-risk of causing a heart attack. Recent experimental data has suggested that the force the blood exerts on the wall of the artery (shear stress) may be important in promoting plaque growth and even rupture.
Measurement of shear stress in humans is challenging and is currently performed via a coronary angiogram combined with specialist invasive imaging. These images allow us to create a three-dimensional model of the arteries to the heart on a computer. Shear stress can then be calculated using highly specialist software that models blood flow in the arteries. At present, shear stress calculations can only be performed following an invasive medical procedure. This means we cannot calculate shear stress for the majority of patients with suspected coronary artery disease.
CT coronary angiography (CTCA) is an established, safe, rapid and convenient non–invasive method to diagnose the presence of coronary artery disease. CTCA also provides useful information on the size and composition of coronary plaque. However, the ability of CTCA to calculate shear stress in coronary arteries is unknown. If this project is successful, then shear stress calculations could be performed based on CTCA images, which would allow clinicians to explore whether this force is responsible for plaque growth or rupture in humans.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 77074 0
Dr Adam J. Brown
Address 77074 0
Monash Cardiovascular Research Centre
Department of Medicine
Monash University
246 Clayton Road
Clayton
Victoria
3168
Country 77074 0
Australia
Phone 77074 0
+61 3 9594 2726
Fax 77074 0
+61 3 9594 6939
Email 77074 0
[email protected]
Contact person for public queries
Name 77075 0
Dr Adam J. Brown
Address 77075 0
Monash Cardiovascular Research Centre
Department of Medicine
Monash University
246 Clayton Road
Clayton
Victoria
3168
Country 77075 0
Australia
Phone 77075 0
+61 3 9594 2726
Fax 77075 0
+61 3 9594 6939
Email 77075 0
[email protected]
Contact person for scientific queries
Name 77076 0
Dr Adam J. Brown
Address 77076 0
Monash Cardiovascular Research Centre
Department of Medicine
Monash University
246 Clayton Road
Clayton
Victoria
3168
Country 77076 0
Australia
Phone 77076 0
+61 3 9594 2726
Fax 77076 0
+61 3 9594 6939
Email 77076 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
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.