Lower Extremity Peripheral Arterial Disease and Exercise Ischemia (CLASH)

This is an interventional supportive care trial for Peripheral Arterial Diseases Read More

Inclusion Criteria:

• Age ≥ 18 years old
• Insured under the French social security system (according to French law)

• Presence of lower-extremity peripheral artery disease, defined by:

  • A resting ankle-brachial index (ABI) ≤ 0.90
  • OR if resting ABI > 0.90 and < 1.00, a decrease in recovery ankle systolic pressure or in recovery ABI from treadmill exercise higher than 30% or 20%, respectively (AHA recommendations).
  • OR if resting ABI > 1.40, a toe pressure index ≤ 0.70
• Maximal walking distance on treadmill (3.2 km/h, 10% grade) < 500m (a)

• Complain of exertional lower limbs pain that can begin or not at rest, causes the participant to stop walking and relieves or lessens within 10 minutes of rest (assessed using the San Diego questionnaire AND confirmed during treadmill testing) (b)

  1. As assessed during the medical appointment.
  2. According to our inclusion criteria, patients' leg symptoms that fell within the following leg symptom categories could be included in the study:

  i) Intermittent claudication. Patients that experience exertional calf pain that does not begin at rest and that forces them to stop walking and that relieves or lessens within 10 minutes of rest; ii) Atypical exertional leg pain/stop. This category can encompass diverse situations of exertional leg symptoms. In the present study, patients in this category were included if they experience exertional pain that does not begin at rest and that forces them to stop walking, but that do not involve only the calf(s) but also thigh(s) and/or buttock(s). Further, the exertional leg pain relieves or lessens within 10 minutes of rest; iii) Leg pain on exertion and rest. In this category, patients sometimes experience exertional leg pain at rest when they are standing still or sitting. On exertion, patients also experience a walking pain as described above. As reminded by Criqui et al., this category of patients with "pain at rest" should not be confused with patients that experience "rest pain", which usually refers to patients with such severe advanced PAD that ischemic pain is present even at rest. Patients with ischemic rest pain were not included in the study.

Non-Inclusion criteria

• Exercise limitation due to symptoms not related to an arterial insufficiency in the lower limbs (e.g., dyspnea, angina pectoris)
• Contraindication for walking (Abdominal aortic aneurysm > 4 cm)
• Myocardial infarction and no stroke in the last 3 months
• Critical limb ischemia, amputation.
• Pregnant women
• Adult subject to legal protection (guardianship or tutelage measure) and persons deprived from their liberty (according to French law).
• Patient living more than 50 km from the university hospital
• Patient unable to understand the instructions of the study