The Holistic Peripheral Artery Disease Management Trial (OPTIMAL)

Not Applicable

Recruiting

• Conditions: Peripheral artery disease; Cardiovascular - Diseases of the vasculature and circulation including the lymphatic system

• Registration Number: ACTRN12621001475831
• Lead Sponsor: James Cook University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-10-28
• Last Update Posted: 10 October 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 246

Inclusion Criteria

1. PAD, defined from prior diagnosis by an appropriately qualified specialist including vascular surgeon, cardiologist or internal medicine specialist. PAD diagnosis will consider symptoms, clinical examination, past requirement for surgical treatment of PAD and available investigations including ankle brachial index (ABI), duplex ultrasound or angiography. Acceptable definitions will include ABI <0.9 or >1.4, absence of pedal pulses with relevant symptoms, prior requirement for lower limb peripheral artery open surgical or endovascular procedure to treat athero-thrombosis or imaging (including ultrasound, digital subtraction angiography, computed tomography or magnetic resonance imaging) evidence of lower limb artery stenosis (at least 50%) or occlusion;
2. At least 18 years old and able to provide valid informed consent;
3. Able to verbally communicate with the trial staff in English.

Exclusion Criteria

1. Enrolled in another clinical trial;
2. Optimal risk factor control (i.e. PAD-medical score 6);
3. Unwilling or unable to engage with technology required for intervention;
4. Terminal illness with a prognosis of less than 6 months.

Study & Design

• Study Type: Interventional
• Study Design: Not specified