ANZCTR - Registration

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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

Condition category

Condition code

Cardiovascular

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]

Prevention

Comparator / control treatment

Usual care (dobutamine echo and standard responses to a positive or negative test).

Control group

Active

Outcomes

Primary outcome [1]

Reduction of cardiac events

Timepoint [1]

At 30 days post-operatively

Secondary outcome [1]

Improvement in quality of life

Timepoint [1]

At 6 months

Secondary outcome [2]

Reduction of cost relative to standard therapy

Timepoint [2]

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?

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]

Government body

Name [1]

National Health and Medical ResearchCouncil (NHMRC), Project grant STRATIFY study

Address [1]

Country [1]

Australia

Primary sponsor type

Individual

Name

Professor T Marwick

Address

Country

Secondary sponsor category [1]

None

Name [1]

Nil

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Princess Alexandra Hospital

Ethics committee address [1]

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

11/01/2005

Ethics approval number [1]

PAH2005/018

Ethics committee name [2]

Queen Elizabeth II Hospital

Ethics committee address [2]

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

Approval date [2]

11/01/2005

Ethics approval number [2]

PAH2005/018

Ethics committee name [3]

Logan Hospital

Ethics committee address [3]

Ethics committee country [3]

Australia

Date submitted for ethics approval [3]

Approval date [3]

11/01/2005

Ethics approval number [3]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Ms Helen Branagan

Address

Department of Medicine
University of Queensland
Level 4
Princess Alexandra Hospital
Brisbane QLD 4102

Country

Australia

Phone

+61 7 32406437

Fax

+61 7 32405399

hbranagan@soms.uq.edu.au

Contact person for scientific queries

Name

Professor Tom Marwick

Address

Department of Medicine
University of Queensland
Level 4
Princess Alexandra Hospital
Brisbane QLD 4102

Country

Australia

Phone

+61 7 32405340

Fax

+61 7 32405399

t.marwick@uq.edu.au

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

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

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