Exercise positron emission technology (PET) imaging of the heart to predict cardiac complications after major cancer surgery

Not Applicable

Completed

• Conditions: Cardiac disease; Cancer; Cardiovascular - Coronary heart disease; Cancer - Any cancer

• Registration Number: ACTRN12614000283673
• Lead Sponsor: Marissa Ferguson

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-03-18
• Study Completion: 2016-12-31
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 26

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

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

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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).[Day 0 (day of performing cardiac PET test).]

Secondary Outcome Measures

Name	Time	Method
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).<br>[Day 0-30 postoperatively (multiple assessments on days 0, 1, 2, 3, one week, two weeks, and at 30 days postoperatively).];Assessment of potential false-positive rates of exercise cardiac PET imaging (evidence of ischaemia in low risk patients without demonstrable myocardial ischaemia).<br>[Day 0-30 postoperatively (multiple assessments on days 0, 1, 2, 3, one week, two weeks, and at 30 days postoperatively).];Comparison of semi-quantitative assessment of severity and distribution myocardial ischaemia using PET imaging vs. SPECT MPI.[Day 0 (after PET and MPI completed)];Feasibility of performing 'EndoPAT' testing of endothelial function and blood sampling for troponin and BNP at the time of exercise testing.[Day 0.]