ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

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]

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

Condition category

Condition code

Cardiovascular

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]

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]

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]

Baseline

Secondary outcome [1]

The secondary aim of this study is to assess whether there is a correlation between CTCA- and IVUS-defined ESS measurements.

Timepoint [1]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Monash Medical Centre - Clayton campus - Clayton

Recruitment postcode(s) [1]

3168 - Clayton

Funding & Sponsors

Funding source category [1]

University

Name [1]

Monash University

Address [1]

Monash Cardiovascular Research Centre
Department of Medicine
Monash University
246 Clayton Road
Clayton
Victoria
3168

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Monash Health Ethics Committee

Ethics committee address [1]

Monash Health
Monash Medical Centre
246 Clayton Road
Clayton
Victoria
3168

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

10/02/2017

Approval date [1]

29/05/2017

Ethics approval number [1]

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

Dr Adam J. Brown

Address

Monash Cardiovascular Research Centre
Department of Medicine
Monash University
246 Clayton Road
Clayton
Victoria
3168

Country

Australia

Phone

+61 3 9594 2726

Fax

+61 3 9594 6939

adam.brown@monash.edu

Contact person for public queries

Name

Adam J. Brown

Address

Monash Cardiovascular Research Centre
Department of Medicine
Monash University
246 Clayton Road
Clayton
Victoria
3168

Country

Australia

Phone

+61 3 9594 2726

Fax

+61 3 9594 6939

adam.brown@monash.edu

Contact person for scientific queries

Name

Adam J. Brown

Address

Monash Cardiovascular Research Centre
Department of Medicine
Monash University
246 Clayton Road
Clayton
Victoria
3168

Country

Australia

Phone

+61 3 9594 2726

Fax

+61 3 9594 6939

adam.brown@monash.edu

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.

Trial Review

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