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 @ 10:04 PM
Ignite Modification Date:
2025-12-24 @ 10:04 PM
NCT ID:
NCT00590135
Eligibility Criteria:
Inclusion Criteria:
* Mild to moderate calcific AS of a tricuspid or bicuspid aortic valve
* Echocardiographic derived mean pressure gradient \>10 mmHg and an aortic valve area of 0.9 to 1.7 cm2 by continuity equation.
* Laboratory evidence of LDL-c\>70 mg/dl within 12 months prior to recruitment.
Exclusion Criteria:
* Left ventricular ejection fraction \<50%
* Valvular area of 0.9 cm2 and a mean gradient \>30 mmHg
* Rheumatic heart disease
* \>Moderate (2+) aortic insufficiency
* Prior statin therapy to include: \>10 mg of atorvastatin (Lipitor) or \>20 mg of other HMG-CoA Reductase Inhibitors (statins)
* End-stage renal disease (ESRD)
* History of thoracic radiation
* Unable or unwilling to sign informed consent
* Unable to unwilling to return for follow-up
* Other clinically important renal, pulmonary, hepatic, neurological, endocrine, or hematological disorders, vasculitis, or any other situation or medical condition that, in the investigator's opinion, would make survival for the duration of the study unlikely, or would otherwise interfere with optimal participation in the study or produce a significant risk to the patient
* Severe pulmonary hypertension (\>55 mmHg)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00590135
Study Brief:
Protocol Section:
NCT00590135