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 @ 7:54 PM
Ignite Modification Date:
2025-12-24 @ 7:54 PM
NCT ID:
NCT02791204
Eligibility Criteria:
Inclusion Criteria for Healthy Control Population:
1. At least 18 years of age
2. Normal (0.9-1.2) Ankle Brachial Index
Inclusion Criteria for patients undergoing clinically indicated myocardial perfusion study:
1\) At least 18 years of age 2) scheduled for stress myocardial perfusion imaging study for clinically indicated reason
-Inclusion Criteria for PAD Patient Population:
1. At least 18 years of age
2. Evidence of significant obstructive disease for one or multiple lower extremity arteries, as identified by CT angiography, ultrasound, or MR imaging or an abnormal ankle-brachial index or toe-brachial index
3. Previously diagnosed diabetes mellitus (type I or II), based on any of the following criteria: fasting plasma glucose great than 126 mg/dl on 2 separate occasions, glycated hemoglobin (HbA1c) greater than 6.5% on 2 separate occasions, fasting plasma glucose greater than 200 mg/dl 2 hours following an oral glucose tolerance test on 2 separate occasions, or fasting plasma glucose and HbA1c above normal limits on same visit.
4. scheduled for revascularization due to obstructive blood flow in the lower extremities.
Exclusion Criteria for Healthy Control Population:
1. Unable to give informed consent
2. Enrolled in another trial
3. Preexisting medical conditions affecting the vascular system including, but not limited to: Coronary Artery Disease, Peripheral Arterial Disease, diabetes, cancer, hypertension, history of smoking
4. Pregnant or nursing
Exclusion Criteria for PAD Patient Population:
1. Unable to give informed consent or follow-up
2. Enrolled in another trial
Exclusion Criteria for patients undergoing clinically indicated myocardial perfusion study:
1\) Unable to give informed consent
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02791204
Study Brief:
Protocol Section:
NCT02791204