Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000056493
Ethics application status
Approved
Date submitted
9/01/2007
Date registered
18/01/2007
Date last updated
18/01/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Study of risk assessment to reduce complications in patients following non cardiac surgery
Scientific title
Study of risk assessment to guide selection of cardioprotective strategy (combinations of bisoprolol, aspirin and simvastatin) to reduce cardiac complications in "at risk" patients following non cardiac surgery
Universal Trial Number (UTN)
Trial acronym
STRATIFY
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiac complications following major non-cardiac surgery 1549 0
Condition category
Condition code
Cardiovascular 1649 1649 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients having major non cardiac surgery are assessed prior to the procedure. If no exclusion criteria are met (see below), they are assessed using a clinical score with one point given for each risk factor. Those patients with 1-2 risk factors are classified as intermediate risk and those with >2 are classified as high risk.
Intermediate risk patients are randomized to bisoprolol only (ie. no further risk evaluation) or usual care (dobutamine echo and standard responses to a positive or negative test). Standard responses to a positive test usually involve use of a standard beta blocker without careful titration to heart rate. A standard response to a negative test involves no specific therapy. Oral bisoprolol is started at 5mg a day, reassessed at one week and if pulse rate remains >60 and other vital signs are stable the dose is increased to 10mg. The bisoprolol is continued for a month following surgery. The patient is reassessed and referred to their general practitioner with a recommendation to continue with a more common beta-blocker.
All high risk patients undergo a dobutamine stress echo. If the results are negative they have usual care and follow up but are not randomized for further study. If the results are positive they are randomized to a triad of oral medications - bisoprolol (to titrate heart rate <60 as above), aspirin (100 mg/d) and simvastatin (40 mg/d) or usual care. Usual care comprises use of a standard beta blocker (as above), with selective use of coronary angiography and coronary intervention, usually guided by the patient’s symptom status). Trial drugs are continued for one month after surgery.
All patients are given a Quality of Life Survey on admission to the trial and at six months.
Electrocardiograms and Troponin levels are done daily for 3 days post operatively and repeated on discharge or Day 7.
All patients are reviewed at one and six months, electrocardiograms are repeated.
Intervention code [1] 1541 0
Prevention
Comparator / control treatment
Usual care (dobutamine echo and standard responses to a positive or negative test).
Control group
Active

Outcomes
Primary outcome [1] 2275 0
Reduction of cardiac events
Timepoint [1] 2275 0
At 30 days post-operatively
Secondary outcome [1] 3982 0
Improvement in quality of life
Timepoint [1] 3982 0
At 6 months
Secondary outcome [2] 3983 0
Reduction of cost relative to standard therapy
Timepoint [2] 3983 0
At 6 months

Eligibility
Key inclusion criteria
Major non cardiac surgery in subjects with one or more of the following risk factors; age over 70years, previous myocardial infarct, diabetes mellitus, angina and chronic heart failure.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Asthma, bradycardia, laparoscopic procedures, and aortic stents.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation by sealed opaque envelope
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using procedures such as coin-tossing and dice-rolling
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
24/05/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
600
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1796 0
Government body
Name [1] 1796 0
National Health and Medical ResearchCouncil (NHMRC), Project grant STRATIFY study
Country [1] 1796 0
Australia
Primary sponsor type
Individual
Name
Professor T Marwick
Address
Country
Secondary sponsor category [1] 1615 0
None
Name [1] 1615 0
Nil
Address [1] 1615 0
Country [1] 1615 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3351 0
Princess Alexandra Hospital
Ethics committee address [1] 3351 0
Ethics committee country [1] 3351 0
Australia
Date submitted for ethics approval [1] 3351 0
Approval date [1] 3351 0
11/01/2005
Ethics approval number [1] 3351 0
PAH2005/018
Ethics committee name [2] 3352 0
Queen Elizabeth II Hospital
Ethics committee address [2] 3352 0
Ethics committee country [2] 3352 0
Australia
Date submitted for ethics approval [2] 3352 0
Approval date [2] 3352 0
11/01/2005
Ethics approval number [2] 3352 0
PAH2005/018
Ethics committee name [3] 3353 0
Logan Hospital
Ethics committee address [3] 3353 0
Ethics committee country [3] 3353 0
Australia
Date submitted for ethics approval [3] 3353 0
Approval date [3] 3353 0
11/01/2005
Ethics approval number [3] 3353 0
PAH2005/018

Summary
Brief summary
More than 50% of patients requiring surgery for enlargement (aneurysm) of the aorta or narrowing of the carotid or limb arteries have coexistent coronary disease. Indeed, cardiac problems account for the majority of operative complications in patients undergoing vascular surgery.

Individuals who have a low cardiac risk from these operations can be identified by clinical evaluation, especially if a stress test is negative. However, if a test is positive, the risk of having a cardiac complication is <20-30%. The optimal response to this finding is still unclear. In this situation, patients are often referred for bypass surgery or coronary balloon angioplasty in order to treat their coronary disease. However, this approach may be inappropriately aggressive, as 70% or more of the patients will undergo their vascular surgery uneventfully. Moreover, patients with vascular disease are often elderly, and have other diseases that make heart operations more difficult and risky than usual. An alternative is the use of medical therapy to protect the heart, but the efficacy of this approach in reducing peri-operative complications is debated.

This multicentre study, based at hospitals in the mainland capital cities of Australia, will examine patients with a positive stress test, and then use the results of the test to identify high and intermediate risk levels. Patients will be excluded from the study if the stress test is strongly positive, and a heart operation is definitely in the patient's best interests. In other situations, where the best approach to therapy is unproven, patients will be randomized to a regimen involving intensive medical therapy to protect the heart, or coronary angiography with the intent of myocardial revascularization if possible. Patients will be followed up for events of the time of surgery, and outcome (including quality of life) will be assessed six months after the operation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27475 0
Address 27475 0
Country 27475 0
Phone 27475 0
Fax 27475 0
Email 27475 0
Contact person for public queries
Name 10730 0
Ms Helen Branagan
Address 10730 0
Department of Medicine
University of Queensland
Level 4
Princess Alexandra Hospital
Brisbane QLD 4102
Country 10730 0
Australia
Phone 10730 0
+61 7 32406437
Fax 10730 0
+61 7 32405399
Email 10730 0
[email protected]
Contact person for scientific queries
Name 1658 0
Professor Tom Marwick
Address 1658 0
Department of Medicine
University of Queensland
Level 4
Princess Alexandra Hospital
Brisbane QLD 4102
Country 1658 0
Australia
Phone 1658 0
+61 7 32405340
Fax 1658 0
+61 7 32405399
Email 1658 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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