Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12609000942257
Ethics application status
Approved
Date submitted
11/03/2009
Date registered
3/11/2009
Date last updated
3/11/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Targeted Disease Management Plan for Patients with Peripheral Arterial Disease.
Scientific title
Effects on atherosclerotic burden and cardiovascular events in a randomized trial of a disease management plan or usual care in asymptomatic and symptomatic patients with peripheral arterial disease
Universal Trial Number (UTN)
Trial acronym
TEMPLATE study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peripheral Arterial Disease. 4453 0
Condition category
Condition code
Cardiovascular 4722 4722 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Lifestyle intervention: low fat diet, exercise, smoking cessation. Frequent review by General practioner (GP) for titration of medications – statins, beta blockers.
Participation in a one hour exercise program once a week for twelve weeks. A small group who exercise on a circuit including treadmill, bicycle and floor exercises supervised by physiotherapist and exercise physiologist
Program repeated once a year for three years.
Intervention code [1] 4198 0
Early detection / Screening
Comparator / control treatment
Usual care. Participation in a one hour exercise program once a week for twelve weeks. A small group exercise program on a circuit including treadmill, bicycle and floor exercises supervised by physiotherapist and exercise physiologist
Usual review by GP and other health practioners throughout the study period. Medication as prescribed without titration.
Control group
Active

Outcomes
Primary outcome [1] 5590 0
Atherosclerotic burden (carotid intima-medial thickness, dobutamine echocardiogram) at 36 months. Ultrasound used to measure the carotid intima-medial thickness.
Timepoint [1] 5590 0
12, 24 and 36 months after randomisation
Primary outcome [2] 253149 0
Cardiovascular events; Cardiac death/Myocardial Infarction/ Stroke
Timepoint [2] 253149 0
6, 12, 24 and 36 months after randomisation
Secondary outcome [1] 9419 0
Quality of life measurements; SF12, Hospital Anxiety and Depression Scale (HADS), Vascular Quality of Life Questionnaire (VascuQOL).
Timepoint [1] 9419 0
Baseline, 6, 12 .24 and 36 months after randomisation
Secondary outcome [2] 262050 0
Biochemistry markers: Cholesterol, blood glucose, creatinine - blood tests by an accreditated pathology service.
Timepoint [2] 262050 0
baseline, 6, 12 .24 and 36 months after randomisation.
Secondary outcome [3] 262051 0
Physical parameters: Body Mass Index (BMI), Blood pressure, Pulse. Performed by exercise physiologists.
Timepoint [3] 262051 0
baseline, 6, 12, 24 and 36 months after randomisation.

Eligibility
Key inclusion criteria
All patients included will have a positive Edinburgh Claudication Scale and/or positive ankle Brachial Index.
These patients will be assessed into two groups of patients;
Low risk group with 1-2 of these risk factors
High Risk group with 3 or more of these risk factors.
Age 50 yrs old or more
Exercise <30 min. a day (what type of exercise performed)
Smoking Current (type/amount) Previous/Passive
Obesity Body Mass Index >28
Social behaviour Depression/history of depression.
Hypertension Systolic >139mm Hg and Diastolic >89mm Hg
Renal impairment Creatinine, = 180 mmol/dL
Blood Glucose level Fasting Glucose, =126 mg/dL
Hyperlipidemia Low density lipid (LDL) >130mg/dL
High Density lipid(HDL) <50mg/dL (women) <49mg/dL (men)
Minimum age
50 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who have had vascular surgery or plan to have vascular surgery for claudication.
Patients with no risk factors.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
After suitability is confirmed by data entry, the database will generate an enrolment number and randomization statement.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation sequence is generated by random number generation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
16/02/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
280
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4644 0
Government body
Name [1] 4644 0
National Health and Medical Research Council (NHMRC)
Country [1] 4644 0
Australia
Primary sponsor type
Government body
Name
National Health and Medical Research Council (NHMRC)
Address
GPO box 1421 Canberra ACT 2601
Country
Australia
Secondary sponsor category [1] 4191 0
None
Name [1] 4191 0
Address [1] 4191 0
Country [1] 4191 0
Other collaborator category [1] 611 0
Other Collaborative groups
Name [1] 611 0
Baker Heart Institute
Address [1] 611 0
75 Commercial Road
Melbourne, Victoria 3004

PO Box 6492, St Kilda Road Central
Victoria 8008
Country [1] 611 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6680 0
Princess Alexandra Hospital Human research ethics committee
Ethics committee address [1] 6680 0
Princess Alexandra Hospital
Ipswich Road
WOOLLOONGABBA QLD 4102
Ethics committee country [1] 6680 0
Australia
Date submitted for ethics approval [1] 6680 0
Approval date [1] 6680 0
29/01/2009
Ethics approval number [1] 6680 0
221/2009; UQ Ethics 2009000187; PAH Ethics 2008/221

Summary
Brief summary
We will study patients with peripheral arterial disease (PAD) – either symptomatic claudication (measured by the Edinburgh claudication scale) or asymptomatic (ankle brachial index measurement), with a history of having one or more of risk factors. Future cardiovascular risk will be defined by a trained study nurse, starting with a standard clinical history and lipid profile, and carotid imaging for plaque using a Intima thickness scan (IMT) and Clinical variables (age, diabetes, cardiac history) and biochemistry (renal function, lipid status) will be available for risk adjustment in the multivariate analyses. Other baseline measures will include quality of life. Patients will then be randomized into usual care or a PAD-specific disease management program (DMP).
Patients in the usual care group will have current PAD guidelines sent to the treating General Prcationer (GP), but statin use will be restricted by the current Pharamceutical benefits Scheme (PBS) guidelines.
Total cholesterol (TC) >6.5 mmol/l or >5.5 mmol/l if High Density lipid (HDL) <1mmol/l).
The DMP group will have a full clinical evaluation, education (including contact with Heartline), medical therapy of Blood Pressure(BP), glucose and lipids to current targets, smoking cessation, weight reduction and exercise advice. Patients in this group will receive aspirin 100 mg/d. Generic simvastatin will be given to those ineligible for statins according to Pharmaceutical Benefits scheme (PBS) guidelines, to a target LDL-C <2.0 mmol/l.
Patients in the DMP group with one or more of the modified risk factors will undergo Dobutamine Stress echocardiogram (DSE), using standard protocols.Those with a positive study will be started on metoprolol (titrated to a resting Heart rate (HR) of 60 beats per min.), excluding patients with contra-indications to beta-blockade. Coronary angiography will be arranged for those at highest risk (>30%). Patients already on beta blockers account for <15% of major noncardiac surgery patients in our experience: if randomized to the DMP group, they will be optimized to a resting HR of 60/min.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29379 0
Address 29379 0
Country 29379 0
Phone 29379 0
Fax 29379 0
Email 29379 0
Contact person for public queries
Name 12626 0
Helen Branagan
Address 12626 0
School of Medicine
University of Queensland
Princess Alexandra Hospital
Ipswich Road
Wooloongabba 4102
Queensland Australia
Country 12626 0
Australia
Phone 12626 0
+617 32406437
Fax 12626 0
+617 32405399
Email 12626 0
[email protected]
Contact person for scientific queries
Name 3554 0
Professor Thomas Marwick
Address 3554 0
School of Medicine
University of Queensland
Princess Alexandra Hospital
Ipswich Road
Wooloongabba 4102
Queensland Australia
Country 3554 0
Australia
Phone 3554 0
+617 32405340
Fax 3554 0
+617 32405399
Email 3554 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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.