None listed
Conditions
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.
Interventions
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.
Sponsors
National Health and Medical Research Council (NHMRC)
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
50 Years to 100 Years
Healthy volunteers
No
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)
Exclusion criteria
Patients who have had vascular surgery or plan to have vascular surgery for claudication. Patients with no risk factors.
Outcome results
None listed