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 @ 10:23 PM
Ignite Modification Date:
2025-12-24 @ 10:23 PM
NCT ID:
NCT02078635
Eligibility Criteria:
Inclusion Criteria:
Eligible participants will be:
1. Adult males that are within 30% of their target LDL-cholesterol for the low or moderate risk category according to the 2012 Canadian Cardiovascular Society Guidelines.
2. Postmenopausal women that are within 30% of their target LDL-cholesterol for the low or moderate risk category according to the 2012 Canadian Cardiovascular Society Guidelines.
Participants will have the following characteristics:
* BMI 25-40 kg/m2 with body weight that has remained constant (within ±2kg) over the last 3 months preceding the onset of the study.
* Measurable arterial thickening at screening (carotid intima-media thickness of \>1.0mm)
* Plus at least 1 of the following 3 criteria:
* are treated with statins
* are statin intolerant
* have refused statin treatment after consultation with the appropriate physician
Exclusion Criteria:
Individuals with the following conditions will be excluded:
* major cardiovascular event
* stroke or
* myocardial infarction
* Cardiac conditions that compromise normal function
* mitral valve disease
* heart failure
* angina
* familial hypercholesterolemia
* secondary causes of hypercholesterolemia
* hypothyroidism (unless treated and on a stable dose of L-thyroxine)
* renal or liver disease
* diabetes
* serum triglycerides \>4.5 mmol/L
* uncontrolled blood pressure
* major disability
* disorders requiring continuous medical attention and treatment
* chronic heart failure
* liver disease
* renal failure
* cancer (except non-melanoma skin cancer--basal cell, squamous cell)
* chronic infections (bacterial or viral)
* chronic inflammatory diseases ( lupus, ulcerative colitis)
* other autoimmune diseases (eg celiac disease or gluten sensitivity)
* major surgery \<6 months prior to randomization
* conditions that make them unsuitable for MRI (e.g. have metal implants or are claustrophobic)
* alcohol consumption \>2 drinks/ day
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT02078635
Study Brief:
Protocol Section:
NCT02078635