ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12619001560189

Ethics application status

Approved

Date submitted

10/10/2019

Date registered

12/11/2019

Date last updated

12/11/2019

Date data sharing statement initially provided

12/11/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

Coronary heart disease after liver transplantation

Scientific title

Quantifying the Risk of Accelerated Coronary Atherosclerosis following Liver Transplantation: CALT Study (Coronary Atherosclerosis After Liver Transplantation)

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

Trial acronym

CALT

Linked study record

Health condition

Health condition(s) or problem(s) studied:

liver transplantation

coronary artery disease

Condition category

Condition code

Cardiovascular

Coronary heart disease

Oral and Gastrointestinal

Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure

Study type

Observational

Patient registry

False

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

Study design
Study the effect of liver transplantation on the progression of atherosclerosis.

Inclusion criteria:
As per current Victorian Liver Transplant Unit guidelines, all intermediate-high risk patients undergo outpatient Computed tomography coronary angiography (CTCA) as a pre-transplant work-up. In this study, patients that have undergone CTCA before LT are invited to undergo a repeat CTCA a minimum of two years after LT with serial biomarkers. Each CT scan will take approximately 30 minutes. As this study aims to recruit only patients with a prior clinically indicated CT scan, we would only aim to observe each participant for the duration of the CT study. Blood tests will only be performed once at the same encounter.

Intervention code [1]

Diagnosis / Prognosis

Comparator / control treatment

Controls will be chosen among liver disease patients that underwent LT work-up during this time, who did not undergo transplantation. These patients would have undergone a CT scan for a pre-emptive liver transplant work-up but did not proceed to liver transplantation as per the treating physician's directive. The time period that these patients underwent assessment is between 2012-2017.

Control group

Historical

Outcomes

Primary outcome [1]

Assessment of progression of subclinical atherosclerosis including qualitative assessment of plaque pre and post liver transplant. Qualitative assessment involves individual assessment of each CT coronary angiogram to evaluate for severity and extent of coronary artery disease

Timepoint [1]

At least 2 years following liver transplantation

Primary outcome [2]

coronary calcium score pre and post LT compared to the matched control population on CT scan.

Timepoint [2]

At least 2 years following liver transplantation

Primary outcome [3]

Assess atherosclerosis in pre and post liver transplant CT scans using quantitative measures of plaque assessment. Quantitative measures of plaque will include a measure of coronary plaque burden (%) on CT coronary angiography

Timepoint [3]

at least 2 years following liver transplantation

Secondary outcome [1]

Assessment of cholesterol profile including low density lipoprotein on serum assay

Timepoint [1]

Patients in this trial will only be assessed at one time point of at least 2 years following liver transplantation

Secondary outcome [2]

High density lipoprotein on serum assay

Timepoint [2]

at time of CT scan

Secondary outcome [3]

total cholesterol on serum assay

Timepoint [3]

at time of repeat CT scan

Eligibility

Key inclusion criteria

1. Patients who have undergone a CT coronary angiogram prior to liver transplantation.
2. A time period of at least 2 years following liver transplantation
3. Subjects who had a CT coronary angiogram without significant artefacts

Minimum age

18 Years

Maximum age

80 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

- severe renal dysfunction eGFR <30
- contrast allergy
- prior CT demonstrating extensive coronary disease or coronary stents

Study design

Purpose

Natural history

Duration

Longitudinal

Selection

Case control

Timing

Prospective

Statistical methods / analysis

Statistical analyses for all studies will be performed using Stata (StataCorp, TX, USA). Continuous variables will be described as mean and standard deviation and be compared using Student’s t test. Categorical variables will be described as frequencies and percentages and compared using Fisher’s exact or chi-square tests as appropriate. For comparison of prevalence and progression of CT derived plaque burden in this population, adjustment for age, sex and cardiac risk factors will be undertaken.

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

18/11/2019

Actual

Date of last participant enrolment

Anticipated

30/08/2020

Actual

Date of last data collection

Anticipated

30/12/2020

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Austin Health - Austin Hospital - Heidelberg

Recruitment postcode(s) [1]

3084 - Heidelberg

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Austin Hospital Research fund

Address [1]

Department of Cardiology
Level 5 Austin Tower
145 Studley Road, Heidelberg 3084 VIC

Country [1]

Australia

Primary sponsor type

Individual

Name

A/Prof Omar Farouque

Address

Director of Cardiology
Department of Cardiology
Level 5 Austin Tower
145 Studley Road, Heidelberg 3084 VIC

Country

Australia

Secondary sponsor category [1]

Individual

Name [1]

Dr Anoop Koshy

Address [1]

Cardiologist and Cardiology Research Fellow
Department of Cardiology
Level 5 Austin Tower
145 Studley Road, Heidelberg 3084 VIC

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Austin Human Research Ethics Committee

Ethics committee address [1]

Austin Hospital 
145 studley road
Heidelberg 3084 VIC

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

08/04/2018

Approval date [1]

29/06/2018

Ethics approval number [1]

HREC/17/Austin/582

Summary

Brief summary

Liver disease affects over 5 million Australians. In patients with advanced liver disease, liver transplantation is a valuable yet scarce resource with the ability to transform the lives of patients. Our research at Austin Health has shown that cardiovascular disease is a leading cause of early and late adverse outcomes after liver transplantation. The development of cardiovascular disease may limit the benefit of liver transplantation. A proposed mechanism for this observation is accelerated development of plaque build-up in coronary arteries, also known as atherosclerosis.  Atherosclerosis is a condition that can increase the risk of heart attack in patients after liver transplantation.

Computed Tomography (CT) imaging of coronary arteries can be performed in patients to assess their cardiac risk before liver transplantation. Plaque build-up in coronary arteries identified on CT imaging has been shown to adversely impact outcomes at the time of transplantation. However, no studies have evaluated the progression of plaque build-up in patients after transplantation. If liver transplantation causes accelerated atherosclerosis in coronary arteries, the current algorithms for surveillance and therapy of cardiovascular risk may need to be redefined. 

We propose to undertake repeat CT imaging of the coronary arteries at least two years after liver transplantation, in patients who had CT imaging before transplantation. The aim is to assess whether transplantation is a risk factor for progression of plaque build-up, which can predispose to future heart attack. The CT imaging of liver transplant patients will be compared to a control group of liver disease patients who did not undergo transplantation.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

A/Prof Omar Farouque

Address

Level 5, Austin Tower
Austin Hospital
145 Studley Road
Heidelberg 3084

Country

Australia

Phone

+61424513325

Fax

[email protected]

Contact person for public queries

Name

Anoop Koshy

Address

Level 5, Austin Tower
Austin Hospital
145 Studley Road
Heidelberg 3084

Country

Australia

Phone

+61432661842

Fax

[email protected]

Contact person for scientific queries

Name

Anoop Koshy

Address

Level 5, Austin Tower
Austin Hospital
145 Studley Road
Heidelberg 3084

Country

Australia

Phone

+61432661842

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

Data will be stored at Austin Health keeping with the privacy policy and as listed in the high risk ethics approval.

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Plain language summary	No		Current data analysis underway. Will be updated on... [More Details]

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	A prospective natural history study of coronary atherosclerosis following liver transplantation.	2022	https://dx.doi.org/10.1016/j.atherosclerosis.2022.01.020

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically