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 @ 9:17 PM
Ignite Modification Date:
2025-12-24 @ 9:17 PM
NCT ID:
NCT01102504
Eligibility Criteria:
Inclusion Criteria:
* Age 40 - 90 years old,
* Clinically documented carotid symptomatic atherosclerotic disease (symptomatic disease will be considered if one of the following has occurred within 2 months prior to symptoms:
1. Amaurosis fugax
2. Transient ischemic attack (TIA)
3. Stroke (ipsilaterally to the stenotic artery)
* \>30% stenosis on initial B-mode ultrasonography imaging,
* Written, informed consent.
Exclusion Criteria:
* Age \<40 years old or \>90 years old,
* Time from symptom to recruitment \> 2 months
* \<30% stenosis on B-mode ultrasonography imaging,
* Scheduled for surgical/endovascular intervention within 3 months,
* High-dose statin therapy (\>80 mg/day fluvastatin; \>40 mg/day simvastatin; \>40 mg/day pravastatin; \>10 mg/day atorvastatin; \>10 mg/day rosuvastatin 21),
* Other lipid-lowering therapy (fibric acid derivatives, niacin ≥250 mg/day, resins, ezetimibe, fish-oil supplements),
* Chronic use of high dose aspirin \>325 mg/day,
* Allergy or hypersensitivity to tomatoes and tomato products, gadolinium and history of any other significant atopy/allergy (e.g. soy, whey, lutein, lecithin),
* Contraindications for MRI studies including claustrophobia, any MRI non-compatible devices implanted (vascular clips, metal sutures, craniofix, cardiac pacers, endovascular stents/coils, etc.),
* Known renal impairment with creatinine clearance \<50 ml/min (as per departmental policy),
* Women of childbearing potential,
* Inability to consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
90 Years
Study:
NCT01102504
Study Brief:
Protocol Section:
NCT01102504