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 @ 6:59 PM
Ignite Modification Date:
2025-12-24 @ 6:59 PM
NCT ID:
NCT02667457
Eligibility Criteria:
Inclusion Criteria:
For all participants:
1. Males and females age 18 years or greater
2. Able and willing to comply with the study procedures
3. Negative pregnancy test for women of childbearing potential at screening and on the day of administration of 99mTc-rhAnnexin V-128.
For participants with carotid artery disease:
4. Evidence of 50% or more carotid stenosis in one or more carotid arteries on carotid ultrasound within 2 years;
5. Evidence of 50% or more carotid stenosis in the most recent US imaging within 8 weeks prior to 99mTc-rhAnnexin V-128 administration
For control participants:
6. No significant carotid artery disease on carotid ultrasound;
7. No clinically significant abnormalities in baseline laboratory values.
Exclusion Criteria:
1. Previous carotid stending, endarterectomy or stroke;
2. Diagnosis of vasculitis, dissection, or non-atherosclerotic carotid disease (Ehlers-Danlos, Marfans);
3. Pregnancy or lactation;
4. History of any disease or relevant physical or psychiatric condition or abnormal physical finding which may interfere with the study objectives at the investigator judgment;
5. Know hypersensitivity to the investigational product or any of its components;
6. Claustrophobia or inability to lie still in a supine position;
7. Participation in another clinical trial within 4 weeks before study inclusion, except for patients who have participated or who are currently participating in a study without any study drug administration;
8. Unwillingness to provide consent.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02667457
Study Brief:
Protocol Section:
NCT02667457