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:
2025-12-24 @ 11:15 PM
Ignite Modification Date:
2025-12-24 @ 11:15 PM
NCT ID:
NCT03195556
Eligibility Criteria:
Inclusion Criteria:
* Age ≥18 y.o.
* For PAD subjects: known history of unilateral or bilateral PAD diagnosed by reduced ankle-brachial index or angiography and a Rutherford symptom class of 4-6.
Exclusion Criteria:
1. Major medical illness other than PAD affecting the limb (muscle disease, blood diseases that influence flow or rheology, severe heart failure \[NYHA class IV or LVEF \<30%\]).
2. Pregnant or lactating females
3. Hypersensitivity to any ultrasound contrast agent
4. Known atrial septal defect or large right to left shunt.
5. Hemodynamic instability (hypotension with systolic BP \<90 mm Hg, need for vasopressors)
6. Evidence for ongoing myocardial ischemia
7. For normal controls, any known structural non-arrhythmic cardiovascular disease (coronary artery disease, heart failure, moderate or greater valve disease).
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
99 Years
Study:
NCT03195556
Study Brief:
Protocol Section:
NCT03195556