Targeted Disease Management Plan for Patients with Peripheral Arterial Disease.

Not Applicable

Recruiting

• Conditions: Peripheral Arterial Disease.; Cardiovascular - Diseases of the vasculature and circulation including the lymphatic system

• Registration Number: ACTRN12609000942257
• Lead Sponsor: ational Health and Medical Research Council (NHMRC)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-11-03
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 280

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Atherosclerotic burden (carotid intima-medial thickness, dobutamine echocardiogram) at 36 months. Ultrasound used to measure the carotid intima-medial thickness.[12, 24 and 36 months after randomisation];Cardiovascular events; Cardiac death/Myocardial Infarction/ Stroke[6, 12, 24 and 36 months after randomisation]

Secondary Outcome Measures

Name	Time	Method
Quality of life measurements; SF12, Hospital Anxiety and Depression Scale (HADS), Vascular Quality of Life Questionnaire (VascuQOL).[Baseline, 6, 12 .24 and 36 months after randomisation];Biochemistry markers: Cholesterol, blood glucose, creatinine - blood tests by an accreditated pathology service.[baseline, 6, 12 .24 and 36 months after randomisation.];Physical parameters: Body Mass Index (BMI), Blood pressure, Pulse. Performed by exercise physiologists.[baseline, 6, 12, 24 and 36 months after randomisation.]