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 @ 2:31 AM
Ignite Modification Date:
2025-12-25 @ 2:31 AM
NCT ID:
NCT00990834
Eligibility Criteria:
Inclusion Criteria:
* Primary surgeon's permission.
* Patient is \> 21 years of age.
* Patient will go through a two phase surgery with the two procedures one to eight months apart.
* Patient or representative understands the nature of the study.
* Normal thyroid stimulating hormone (TSH).
* LDL-cholesterol \> 100 mg/dL or highly sensitive C-reactive protein (hsCRP) \> 2.0.
* One of the following risk factors: male \> 45 year old or female \> 55 year old, smoker, hypertension, first degree family history of coronary artery disease \< 55 year old, HDL \<40 mg/dL, chronic kidney disease, diabetes mellitus, previous TIA or stroke, previous coronary artery disease.
Exclusion Criteria:
* Has been on a lipid-lowering medication previously.
* Severe illness (e.g. trauma or sepsis) more than 24 hours before obtaining the first biopsy.
* Less than a 10% reduction of LDL after 3 months of therapy (indicative of non-adherence).
* Contraindications to statins such as liver failure.
* History of underlying muscle disorder.
* Taking amiodarone.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
90 Years
Study:
NCT00990834
Study Brief:
Protocol Section:
NCT00990834