Phase 3Recruiting
Improving Mobility After Revascularization in Peripheral Artery Disease (IMPACT PAD)
IMProving Mobility After revasCularizaTion in Peripheral Artery Disease: The IMPACT PAD Trial
- Sponsor
- Northwestern University (Academic or other)
- Enrolment
- 386 planned
- Conditions
- Peripheral Artery Disease; Intermittent Claudication; Peripheral Vascular Disease; Mobility Limitation; Revascularization
- Interventions
- Home Based Exercise; Nitrate Rich Beetroot Juice; Attention Control; Placebo Beetroot Juice Without Nitrate
- Ages
- adults, older adults
- Registry
- NCT06686121
From the registry
Lower extremity revascularization combined with supervised exercise significantly improves walking performance compared to revascularization alone in people who have PAD without limb threatening ischemia. However, supervised exercise is inaccessible or burdensome for most PAD patients. Investigators hypothesize that home-based exercise combined with lower extremity revascularization will significantly improve walking performance compared to revascularization alone in patients with PAD undergoing revascularization for disabling PAD. Investigators further hypothesize that inorganic nitrate, a major source of nitric oxide (NO) abundant in beetroot juice, will improve walking performance after lower extremity revascularization, compared to placebo. In preclinical models, NO inhibits inflammation, neointimal hyperplasia, thrombosis, and vascular smooth muscle cell migration at sites of revascularization. NO increases angiogenesis and perfusion, repairs skeletal muscle damaged by ischemia, and stimulates mitochondrial activity. In a randomized clinical trial with a 2 x 2 factorial…
Primary outcomes
- Six-Minute Walk Distance 6-month change