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Towards an Effective Treatment for Heart Complications After Surgery (feasibility study)

Secondary Prevention Therapy for Postoperative Myocardial Injury after Noncardiac Surgery (SPECTRE) feasibility trial

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12626000464369
Acronym
SPECTRE
Enrollment
60
Registered
2026-04-15
Start date
2026-04-15
Completion date
2027-04-15
Last updated
2026-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The primary aim of this study is to examine the feasibility of recruiting patients into the trial, the implementability of the prescribed treatments and whether the study treatments are followed. This feasibility study will test whether we can conduct a future, larger trial asking: In patients with early postoperative heart complications, does an early intervention bundle reduce short-term and long-term cardiovascular complications and death? Adults aged 65 years and over, experiencing heart complications after surgery, will be eligible. Recruited individuals will be randomly assigned to receive current standard treatments, or a bundle of care, comprising i) medical therapy (such as aspirin, blood pressure-reducing therapy, diabetes treatment and cholesterol-lowering therapy) and ii) aggressive lifestyle interventions, including smoking cessation, physical activity, dietary modifications and weight management. Barriers and enablers to treatment adherence will be explored individually for each patient, with subsequent recommendations to improve compliance with therapy. All individuals in the study will be followed up for 1 year after surgery, to find out whether they experience further heart complications or do not survive.

Interventions

The intervention group will receive secondary prevention therapy (for coronary artery disease) to treat postoperative myocardial injury (PMI). This will comprise the following: 1. Inpatient Cardiologist review within 72 hours of diagnosis of PMI. This will involve assessment for cardiovascular risk factors, risk stratification (i.e. future risk of myocardial infarction, stroke). Other concurrent cardiac conditions (such as atrial fibrillation, heart failure) will also be assessed, and recommen

The intervention group will receive secondary prevention therapy (for coronary artery disease) to treat postoperative myocardial injury (PMI). This will comprise the following: 1. Inpatient Cardiologist review within 72 hours of diagnosis of PMI. This will involve assessment for cardiovascular risk factors, risk stratification (i.e. future risk of myocardial infarction, stroke). Other concurrent cardiac conditions (such as atrial fibrillation, heart failure) will also be assessed, and recommendations (for optimisation, ongoing treatment) will be provided, if indicated. 2. Cardiac rehabilitation (8 sessions) coordinated by Royal Melbourne Hospital Cardiac Rehabilitation Program 3. Risk factor modification (diabetes, hypertension, hyperlipidaemia). Blood pressure (BP) measurements during admission will be reviewed, for evidence of poorly controlled hypertension (systolic BP 130mmHg or greater, and/or diastolic BP 80mmHg or greater). HbA1c will be measured within 72 hours of diagnosis of PMI; values greater than 7% or 53mmol/mol will prompt more aggressive treatment of diabetes (or new diagnosis of diabetes). The Cardiology team will recommend treatments to optimise glycaemic control or, if required, obtain advice from the Endocrinology team regarding optimisation of diabetes. Lipid profile (including low-density lipoprotein [LDL] levels) will also be measured within 72 hours of diagnosis of PMI. LDL values 1.8mmol/L or greater will prompt treatment with a statin. If the participant is already on a statin, then ezetimibe or PCSK9 inhibitor will be prescribed, to achieve LDL < 1.8mmol/L. This risk factor modification will be initiated by the Cardiology team, and followed up by clinic visits with the research team at 3 months, 6 months and 12 months postoperatively. 4. Pharmacotherapy for secondary prevention of CAD - All participants in the intervention arm will receive aspirin 100mg daily, atorvastatin 40mg daily. If the participant is already on a statin, with LDL 1.8mmol/L or greater at baseline, then ezetimibe 10mg daily will be added to the statin. Lipid profile will be re-checked at 3 months and 6 months postoperatively. If LDL targets are still not being met, despite statin therapy and ezetimibe, evolocumab 420mg (subcutaneous injection) monthly will be added. - Bisoprolol 10mg daily and/or perindopril 10mg daily may be added, at the discretion of the Cardiologist. This will be on an individual basis. These medications will be up-titrated slowly, from 1.25mg daily as a starting dose. - For those participants already on secondary prevention therapy, intensification of therapy will take place, at the discretion of the Cardiologist. This may include addition of a second antiplatelet agent (clopidogrel or ticagrelor), increase in dose of statin (to atorvastatin 80mg daily) or increase in dose of ACE-inhibitor or beta-blocker. - Timing of anti-thrombotic therapy will also depend on the postoperative bleeding risk. The Cardiologist/research team will discuss with the surgical team (parent unit) the safest timing for initiation/intensification of antiplatelet therapy. 5. Lifestyle interventions will be implemented, where applicable, for all participants in the intervention group. These will be implemented, supervised and monitored by the research team. Lifestyle interventions will be reviewed at 3 months, 6 months and 1 year postoperatively. These will comprise the following: Smoking cessation: Applicable if the participant has smoked any cigarettes within the past 6 months. Smoking advice as outlined in quit.org.au, education counselling and assistance with nicotine replacement therapy (if required). Alcohol reduction: Applicable if the participant drinks 10 standard drinks or more per week, or 4 standard drinks or more on any day of the week. If indicated, appropriate education and advice regarding reducing alcohol intake, further counselling/assistance if required Dietary modifications: Applicable if the participant's existing diet does not comprise of at least 80% Mediterranean diet. Education on the Mediterranean diet, with modifications to existing diet (as required) will be provided. Other considerations (such as cultural practices, food intolerances/allergies) will also influence dietary recommendations. Physical activity: Applicable if the participant partakes in exercise that is less than 600 MET-minutes per week (as per the World Health Organisation Global Activity Questionnaire). Gradual increase in physical activity, towards World Health Organisation targets, will be prescribed. These will also incorporate Cardiac Rehabilitation exercises that have been prescribed. Furthermore, post-surgery considerations (such as weight-bearing, heavy lifting) will also be incorporated into physical activity recommendations. TIME FRAME: The intervention will commence within 7 days of surgery, and continue for 1 year postoperatively. This intervention refers to: i) pharmacotherapy; ii) risk factor modification and iii) lifestyle interventions, which will all run simultaneously and continuously for 1 year. At the conclusion of the trial, a Cardiologist will assess the participant's cardiovascular risk and whether they are currently meeting guideline-recommended cardiovascular targets. Post-trial recommendations for secondary prevention therapy, ongoing surveillance and follow-up will then be individualised to the participant. INITIATION OF INTERVENTION: The intervention will be initiated in the surgical ward (during the index admission), and the participant will receive both verbal education (over 15-30 minutes) and written education from a member of the research team, regarding the three components of the intervention (pharmacotherapy, risk factor modification, lifestyle interventions). Written information regarding the diagnosis of PMI, recommendations for pharmacotherapy, risk factor modification and lifestyle intervention will also be sent to the participant's primary care physician. STRATEGIES TO MONITOR ADHERENCE: Adherence to Refills and Medications (ARMS questionnaire) Cardiac Rehabilitation Attendance questionnaire Lifestyle interventions adherence questionnaire (smoking cessation, alcohol intake, physical activity, Mediterranean diet intake) Cardiovascular targets review (systolic and diastolic blood pressure, HbA1c, lipid profile, body mass index, waist circumference measurements) STRATEGIES TO MONITOR FIDELITY OF DELIVERY: Fidelity of Delivery and Fidelity of Receipt records (for research team to complete), which records Cardiac Rehabilitation referral, provision of verbal and written education to the participant (intervention group), provision of written education to the primary care physician (intervention group), appropriate advice (as required) regarding physical activity, dietary intake, smoking cessation, alcohol reduction.

Sponsors

Melbourne Health
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator)

Eligibility

Sex/Gender
All
Age
65 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Age 65 years and over; 2. Undergone non-cardiac surgery 3. Diagnosed with postoperative myocardial injury and 4. High-sensitivity cardiac troponin I (Abbott Architect assay) value of 60 ng/L or greater.

Exclusion criteria

1. Concurrent pulmonary embolism or sepsis; 2. Undergone palliative surgery; 3. Undergone cardiac surgery or interventional cardiology procedure; 4. Individuals who require an interpreter to understand the Participant Information and Consent Form (PICF) and/or medical instructions and 5. Unable to provide valid consent.

Outcome results

None listed

Source: ANZCTR · Data processed: Apr 23, 2026