A Study to Evaluate a Novel Technique to Diagnose Carotid Artery Stenosis
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 18-003098
NCT ID: NCT03464851
Sponsor Protocol Number: IRB 18-126
About this study
The purpose of this study is to determine the accuracy of a new non-invasive device, the Carotid Stenotic Scan (CSS), to check for stenosis of the internal carotid artery (ICA), as compared to a duplex carotid ultrasound.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Outpatients age ≥ 65 years sent to the vascular laboratory for carotid duplex ultrasound examination who have one or more of the following risk factors for atherosclerotic disease:
- Hypertension;
- Hyperlipidemia;
- Diabetes mellitus;
- Known coronary artery/peripheral arterial disease;
- Tobacco use (current or past);
- Family history of early onset cardiovascular disease.
Exclusion Criteria:
- Inability to provide informed consent.
- Prior neck surgery (carotid endarterectomy) or prior carotid artery stenting.
- Aortic stenosis.
- Congestive heart failure.
- Body Mass Index (BMI) > 35.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Thanila Macedo, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available