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Trial registered on ANZCTR


Registration number
ACTRN12614000283673
Ethics application status
Approved
Date submitted
4/01/2014
Date registered
18/03/2014
Date last updated
19/11/2018
Date data sharing statement initially provided
19/11/2018
Date results provided
19/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Exercise positron emission technology (PET) imaging of the heart to predict cardiac complications after major cancer surgery
Scientific title
Exercise Cardiac Positron Emission Technology Imaging in the Preoperative Assessment of Patients Undergoing Major Cancer Surgery: A Prospective Cohort Pilot Study
Secondary ID [1] 283846 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiac disease 290821 0
Cancer 290932 0
Condition category
Condition code
Cardiovascular 291189 291189 0 0
Coronary heart disease
Cancer 291288 291288 0 0
Any cancer

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is an observational study, investigating the feasibility and utility of preoperative exercise cardiac positron emission technology (PET) imaging in identifying patients with cardiac disease preoperatively.
Participants will undergo cardiopulmonary exercise testing (as per standard institutional protocol before major cancer surgery), which involves 10-12 minutes of cycling on a stationary bicycle.
Endothelial function will be assessed non-invasively using a finger tonometry device (EndoPAT) before cardiopulmonary exercise testing. This involves application of a finger-probe on each hand which measures arterial pulse wave amplitude using plethysmographic technology. The testing process involves a resting measurement phase, forearm occlusion (using a blood pressure cuff inflated above systolic blood pressure on one arm for 5 minutes), and a final measurement of the magnitude of reactive hyperaemia after release of the forearm blood flow occlusion.
Exercise PET imaging involves intravenous injection of radiolabelled glucose after peak exercise through an intravenous cannula. The radiolabelled glucose is taken up by ischaemic myocardium in the fasted state after a high fat and low carbohydrate meal. PET imaging then uses detection of emitted positrons to generate a tomographic image of the heart.
Patients must fast for 4-6 hours prior to the cardiopulmonary exercise test, and must consume a high fat, low carbohydrate meal for dinner the evening prior to the test and at 4-6 hours before the exercise test. A range on suggested high fat, low carbohydrate meals options will be provided to participants to choose from.
The total duration of cardiopulmonary exercise testing is approximately 60 minutes. Participants will undergo PET scans 1-2 hours after the cardiopulmonary exercise test. The cardiac PET scan duration is approximately 10 minutes.
Intervention code [1] 288526 0
Diagnosis / Prognosis
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 291177 0
Feasibility of performing cardiac PET (ability to recruit patients, ability of patients to follow fasting and dietary instructions, ability to complete PET testing, feasibility of blinded PET test reporting).
Timepoint [1] 291177 0
Day 0 (day of performing cardiac PET test).
Secondary outcome [1] 306188 0
Ability of exercise cardiac PET imaging to identify exercise-induced myocardial ischaemia amongst patients at high risk for perioperative cardiac complications, compared to conventional SPECT MPI studies (and, if undertaken, echocardiography and coronary angiography).
Timepoint [1] 306188 0
Day 0-30 postoperatively (multiple assessments on days 0, 1, 2, 3, one week, two weeks, and at 30 days postoperatively).
Secondary outcome [2] 306189 0
Assessment of potential false-positive rates of exercise cardiac PET imaging (evidence of ischaemia in low risk patients without demonstrable myocardial ischaemia).
Timepoint [2] 306189 0
Day 0-30 postoperatively (multiple assessments on days 0, 1, 2, 3, one week, two weeks, and at 30 days postoperatively).
Secondary outcome [3] 306190 0
Comparison of semi-quantitative assessment of severity and distribution myocardial ischaemia using PET imaging vs. SPECT MPI.
Timepoint [3] 306190 0
Day 0 (after PET and MPI completed)
Secondary outcome [4] 306191 0
Feasibility of performing 'EndoPAT' testing of endothelial function and blood sampling for troponin and BNP at the time of exercise testing.
Timepoint [4] 306191 0
Day 0.

Eligibility
Key inclusion criteria
Greater than or equal to 18 years of age.
Informed consent.
Patients scheduled to attend pre-admission clinic review and cardiopulmonary exercise testing prior to major surgery at Peter MacCallum Cancer Centre, or patients with an indication for cardiac stress testing
Are assessed as either high predicted risk or low predicted risk: High preoperative risk (Lee Revised Cardiac Risk Index greater than or equal to 2), OR Low preoperative risk (No risk factors other than high risk surgery, using the Lee Revised Cardiac Risk Index)
Participant assessed as being clinically suitable for CPET testing as per the American Thoracic Society guidelines
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unable to provide informed consent
Unable to exercise
Intermediate risk (not meeting criteria for high or low risk groups).
Pregnancy or breastfeeding.
Insulin dependent diabetes mellitus.

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
This study is a pilot study, and a sample size of 40 patients was chosen by the study investigators due to anticipated feasibility. As this is a pilot study, no formal sample size calculations were performed, due to the lack of data upon which to base any sample size calculation.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/05/2014
Actual
10/07/2014
Date of last participant enrolment
Anticipated
28/02/2015
Actual
29/02/2016
Date of last data collection
Anticipated
Actual
31/12/2016
Sample size
Target
40
Accrual to date
Final
26
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 1893 0
Peter MacCallum Cancer Institute - East Melbourne
Recruitment postcode(s) [1] 7666 0
3002 - East Melbourne

Funding & Sponsors
Funding source category [1] 288498 0
Hospital
Name [1] 288498 0
Peter MacCallum Cancer Centre
Country [1] 288498 0
Australia
Funding source category [2] 290266 0
Other Collaborative groups
Name [2] 290266 0
Australian and New Zealand College of Anaesthetists (ANZCA Novice Investigator Grant)
Country [2] 290266 0
Australia
Primary sponsor type
Individual
Name
Marissa Ferguson
Address
Peter MacCallum Cancer Centre
Lansdowne St, East Melbourne VIC 3002
Country
Australia
Secondary sponsor category [1] 287203 0
None
Name [1] 287203 0
Address [1] 287203 0
Country [1] 287203 0
Other collaborator category [1] 277750 0
Hospital
Name [1] 277750 0
Alfred Hospital
Address [1] 277750 0
55 Commercial Rd, Melbourne VIC 3004
Country [1] 277750 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290356 0
Peter MacCallum Cancer Centre
Ethics committee address [1] 290356 0
Ethics committee country [1] 290356 0
Australia
Date submitted for ethics approval [1] 290356 0
10/02/2014
Approval date [1] 290356 0
31/03/2014
Ethics approval number [1] 290356 0

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

Contacts
Principal investigator
Name 45302 0
Dr Marissa Ferguson
Address 45302 0
Peter MacCallum Cancer Centre
Department of Anaesthesia and Perioperative Medicine
Division of Cancer Surgery
Locked Bag 1 A’Beckett St
VIC 8006
Country 45302 0
Australia
Phone 45302 0
+613 9656 1111
Fax 45302 0
Email 45302 0
marissa.ferguson@gmail.com
Contact person for public queries
Name 45303 0
Marissa Ferguson
Address 45303 0
Peter MacCallum Cancer Centre
Department of Anaesthesia and Perioperative Medicine
Division of Cancer Surgery
Locked Bag 1 A’Beckett St
VIC 8006
Country 45303 0
Australia
Phone 45303 0
+613 9656 1111
Fax 45303 0
Email 45303 0
marissa.ferguson@gmail.com
Contact person for scientific queries
Name 45304 0
Marissa Ferguson
Address 45304 0
Peter MacCallum Cancer Centre
Department of Anaesthesia and Perioperative Medicine
Division of Cancer Surgery
Locked Bag 1 A’Beckett St
VIC 8006
Country 45304 0
Australia
Phone 45304 0
+613 9656 1111
Fax 45304 0
Email 45304 0
marissa.ferguson@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
N/A


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.