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 @ 2:07 AM
Ignite Modification Date:
2025-12-25 @ 2:07 AM
NCT ID:
NCT00850460
Eligibility Criteria:
Inclusion Criteria:
* males and females 30-60 yrs old
* experiencing muscle pain, weakness, numbness or cramping that they perceive to interfere with activities of daily living (ADLs), but able to ambulate independently (in order to perform exercise tests)
* muscle symptoms started/ occurred within one year of starting statin treatment or within one year of changing statin brand or dose adjustment
* currently taking a statin (has been taking medications ≥ 80% of the time or at least 5 days/week)
* ≤ 15% probability of having a cardiovascular (CV) event in the next 10 years calculated using an online CV risk calculator (while on current statin) for the questionnaire portion; AND with a low or a moderate American College of Sports Medicine (ACSM) risk stratification for a cardiovascular event during a treadmill test for the full metabolic study
* must agree to have a letter sent to inform the health care provider who prescribed the statin of study participation except for subjects referred by Metropolitan Hospital physicians
Exclusion Criteria:
* concomitant treatment with other lipid-lowering agents
* impaired liver or kidney function ( alanine aminotransferase (ALT) or asparate aminotransferase (AST) ≥ 3x upper limit of normal, creatinine ≥ 3x or creatine phosphokinase (CPK) ≥ 5x upper limit of normal)
* untreated hypo or hyperthyroidism
* current treatment with other medications known to increase risk of myopathy (e.g. cyclosporine, azithromycin, erythromycin and other macrolide antibiotics, azole antifungals, fusidic acid, digoxin)
* documented history of muscle disorder or myopathy other than statin-associated myopathy
* anemia (Hb\< 110 g/dL)
* cancer within 5 years of enrollment except basal or squamous cell carcinoma (CA) of the skin
* diabetes
* HIV-1 infection
* Uncontrolled blood pressure ≥ 160/100
* known coronary artery disease or peripheral vascular disease
* chronic illnesses such as lupus, rheumatoid arthritis, psoriasis
* any condition, that at the investigators' discretion would impact/ bias the study data
* long term oral, nasal, or inhaler steroid use \> 6 months
* on Hormone Therapy except for thyroid replacement
* alcohol consumption ≥ 40 g/day (3 glasses/day wine or beers or binge drinking ≥ 4 glasses/night)
* engaged in significant amounts of sport or strenuous leisure activity (\> 60 min four times per week)
* surgery in the past 6 months except for minor excision/incision procedures,
* 12-L electrocardiogram demonstrating old/new myocardial infarction/ ischemia or other findings that, at the cardiologist's discretion, may put the subject at high risk
* cognitive impairment that prevents comprehension of questionnaires
* inability to read English (questionnaire language)
Exclusions for the metabolic study:
* currently taking beta blockers
* body mass index \> 28 kg/m2
* premenopausal females \< 50 yrs (menopause defined as 12 consecutive months without menstruation (in order to avoid the confounding effect of the menstrual cycle phase on fuel selection)
* physical disability or previous injury that prevents safe exercise testing
* do not meet the magnetic resonance spectroscopy (MRS) prescreening criteria
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
60 Years
Study:
NCT00850460
Study Brief:
Protocol Section:
NCT00850460