Trial Review

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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] 299515 0
Nil known
Universal Trial Number (UTN)
Trial acronym
CALT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
liver transplantation 314764 0
coronary artery disease 314765 0
Condition category
Condition code
Cardiovascular 313096 313096 0 0
Coronary heart disease
Oral and Gastrointestinal 313097 313097 0 0
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] 315775 0
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] 321640 0
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] 321640 0
At least 2 years following liver transplantation
Primary outcome [2] 321844 0
coronary calcium score pre and post LT compared to the matched control population on CT scan.
Timepoint [2] 321844 0
At least 2 years following liver transplantation
Primary outcome [3] 321901 0
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] 321901 0
at least 2 years following liver transplantation
Secondary outcome [1] 375720 0
Assessment of cholesterol profile including low density lipoprotein on serum assay
Timepoint [1] 375720 0
Patients in this trial will only be assessed at one time point of at least 2 years following liver transplantation
Secondary outcome [2] 376768 0
High density lipoprotein on serum assay
Timepoint [2] 376768 0
at time of CT scan
Secondary outcome [3] 376769 0
total cholesterol on serum assay
Timepoint [3] 376769 0
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?
No
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
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 14940 0
Austin Health - Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 28215 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 304009 0
Hospital
Name [1] 304009 0
Austin Hospital Research fund
Country [1] 304009 0
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] 304183 0
Individual
Name [1] 304183 0
Dr Anoop Koshy
Address [1] 304183 0
Cardiologist and Cardiology Research Fellow
Department of Cardiology
Level 5 Austin Tower
145 Studley Road, Heidelberg 3084 VIC
Country [1] 304183 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304503 0
Austin Human Research Ethics Committee
Ethics committee address [1] 304503 0
Ethics committee country [1] 304503 0
Australia
Date submitted for ethics approval [1] 304503 0
08/04/2018
Approval date [1] 304503 0
29/06/2018
Ethics approval number [1] 304503 0
HREC/17/Austin/582

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

Contacts
Principal investigator
Name 97174 0
A/Prof Omar Farouque
Address 97174 0
Level 5, Austin Tower
Austin Hospital
145 Studley Road
Heidelberg 3084
Country 97174 0
Australia
Phone 97174 0
+61424513325
Fax 97174 0
Email 97174 0
omar.farouque@austin.org.au
Contact person for public queries
Name 97175 0
Anoop Koshy
Address 97175 0
Level 5, Austin Tower
Austin Hospital
145 Studley Road
Heidelberg 3084
Country 97175 0
Australia
Phone 97175 0
+61432661842
Fax 97175 0
Email 97175 0
ankoshy@gmail.com
Contact person for scientific queries
Name 97176 0
Anoop Koshy
Address 97176 0
Level 5, Austin Tower
Austin Hospital
145 Studley Road
Heidelberg 3084
Country 97176 0
Australia
Phone 97176 0
+61432661842
Fax 97176 0
Email 97176 0
ankoshy@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Plain language summaryNo Current data analysis underway. Will be updated on... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseA prospective natural history study of coronary atherosclerosis following liver transplantation.2022https://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.