Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2025-12-25 @ 4:03 AM
NCT ID:
NCT02075502
Eligibility Criteria:
Inclusion Criteria:
* Men and women diagnosed with atherosclerotic PAD
* ≥40 years of age
* An abnormal ankle-brachial index (ABI) of ≤.90
* For patients with an ABI \>.90 and \<1.00, a post-exercise ABI drop of 15% or more compared to the resting ABI
* Patients receiving lower extremity ET or peripheral open intervention
* Patients not receiving lower extremity ET or peripheral open intervention but present with stable claudication and an abnormal ABI
Exclusion Criteria:
* Lower extremity amputation(s), including a toe amputation, which interfere (s) with walking on the treadmill
* Individuals with critical limb ischemia defined by ischemic rest pain or ischemic ulcers/gangrene on the lower extremities
* PAD of non-atherosclerotic nature (e.g., fibromuscular dysplasia, irradiation, endofibrosis)
* Coronary artery bypass grafts or major surgical procedures within 6 months prior to screening
* Individuals whose walking exercise is primarily limited by symptoms of chronic obstructive pulmonary disease, angina, or heart failure
* Individuals who are unable to walk on the treadmill at a speed of at least 2 mph for at least 1 minute
* Individuals who have had a myocardial infarction within 3 months prior to screening
* Individuals who demonstrate symptoms consistent with acute coronary syndrome
* Individuals who exhibit ischemia as documented on the 12-lead electrocardiogram including horizontal or down-sloping ST-segment depression ≥0.5 mm at rest and \>1 mm with exercise in 2 contiguous leads, relative to the PR-segment (ST-segment measured 0.08 seconds after the J point, ST-segment elevation ≥1 mm)
* Individuals who have had a transient ischemic attack or stroke 3 months prior to screening
* Individuals with left bundle branch block or sustained ventricular tachycardia (\>30 sec) during screening
* Individuals with uncontrolled hypertension (≥180 systolic or ≥100 diastolic resting blood pressure) during screening
* Treatment with pentoxifylline or cilostazol for the treatment of claudication 4 weeks prior to screening; Patients can be reconsidered for study inclusion following a 1 month washout period from these medications
* Electrolyte abnormalities (e.g., potassium \<3.3 mmol∙Lˉ1 )
* Pregnancy, fertility without protection against pregnancy (for women of childbearing potential, a serum pregnancy test will be performed at screening)
* Incarcerated individuals
* Individuals acutely impaired by alcohol or other illicit drugs
* Poorly controlled diabetes defined as glycated hemoglobin \>12%
* Severely anemic patients (Hgb \<11 g∙dLˉ1 for women and \<10 g∙dLˉ1 for men)
* For patients who have not received peripheral revascularization, an ABI of \>0.90
* For patients with equivocal resting ABIs (0.91-0.99), a drop of \<15% in the post-exercise ABI
* For individuals with non-compressible vessels (ABI \>1.39) who have a toe- brachial index (TBI) \>0.70
* Inability to speak English
* Other clinically significant disease that is, in the opinion of the study team, not stabilized or may otherwise confound the results of the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT02075502
Study Brief:
Protocol Section:
NCT02075502