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 @ 2:01 AM
Ignite Modification Date:
2025-12-25 @ 2:01 AM
NCT ID:
NCT00125060
Eligibility Criteria:
Inclusion Criteria:
* Age greater than 18 years
* Required to have documented atherosclerosis in at least 1 vascular territory defined as: at least moderate (\>3.9mm) aortic atherosclerosis seen on transesophageal echocardiography; or moderate coronary artery disease (\>50% lesion) in at least 1 coronary artery seen at cardiac catheterization; or \>50% carotid lesion seen on ultrasound; or clinically documented peripheral vascular disease.
Exclusion Criteria:
* Patients could be on any statin therapy at entry, but not on a dose equivalent to or greater than 80mg of simvastatin.
* Patients with pacemakers, automated implanted cardioverter defibrillators (AICD), aneurysm clips, abnormal nasopharyngeal anatomy, active peptic ulcer disease, severe dysphagia, elevated baseline liver transaminases and serum creatinine (greater than 2 times the normal), decompensated congestive heart failure or inability to give informed consent.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT00125060
Study Brief:
Protocol Section:
NCT00125060