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 @ 2:34 AM
Ignite Modification Date:
2025-12-25 @ 2:34 AM
NCT ID:
NCT01499134
Eligibility Criteria:
Inclusion Criteria:
* Men and non-pregnant, non-lactating women 45 years of age or older
* Able to give informed consent and complete scheduled visits
* Mild-moderate bilateral lower extremity peripheral arterial disease as defined by an ankle-brachial index (ABI measurement of 0.6-0.9. If a subject has baseline claudication symptoms, the symptoms must be stable for the 3 months preceding enrollment.
* History of hypertension. Blood pressure at the screening visit must be ≤160/100 mmHg and ≥100/60 mmHg for all subjects. If a subject is currently prescribed beta-blocker therapy, BP at the screening visit must be ≤140/90 mmHg. In addition, heart rate must be ≥55 beats per minute if currently prescribed a beta-blocker and ≤60 beats per minute if not currently prescribed a beta-blocker.
* At least moderate risk for CAD.
Exclusion Criteria:
* Participation in another clinical trial
* Ongoing ischemic (resting) limb pain, or lower extremity ulceration due to arterial insufficiency, or an ABI indicating \<0.6 indicating disease potentially requiring revascularization
* History of limb or digit amputation due to arterial insufficiency
* Revascularization of peripheral vessels within the preceding 6 months
* Uncontrolled hypertension as defined by systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg
* Contraindication or allergy to beta blocker therapy
* History of myocardial infarction , coronary revascularization, or a cerebrovascular event within the preceding 6 months
* Class III or IV angina
* Current or past history of New York Heart Association (NYHA) class III or IV heart failure
* Inability to walk on a treadmill for any reason
* Regular use of nitroglycerin or nitrates including oral, transdermal ointment or patch, or sublingual, translingual spray and/or combination agents containing nitrates
* Active liver, pulmonary, infectious or inflammatory process
* History of malignancy within preceding 5 years (excluding basal or squamous cell skin cancer)
* History of any other condition that, in the opinion of the investigators, renders it unsafe for the subject to be enrolled
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01499134
Study Brief:
Protocol Section:
NCT01499134