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 @ 12:27 AM
Ignite Modification Date:
2025-12-25 @ 12:27 AM
NCT ID:
NCT03142867
Eligibility Criteria:
Inclusion Criteria:
* Phase I:
1. Male and female patients (≥18 years of age to 80)
2. Eligible for care at Brooke Army Medical Center
Phase II:
1. Met the criteria for qualification for a percutaneous liver biopsy and completed Phase I
2. Eligible for care at Brooke Army Medical Center
Exclusion Criteria:
* Phase I:
1. Patients with excessive alcohol use will be excluded as defined as \>21 units of alcohol/week for men and 14 units of alcohol/week for women over a 2 year time frame. One drink "unit" or one standard drink is equivalent to a 12-ounce beer, a 4-ounce glass of wine, or a 1-ounce shot of hard liquor.
2. Patients with prior history of liver disease to include chronic hepatitis B or C, hemochromatosis, Wilson's disease, autoimmune hepatitis, primary biliary cirrhosis, primary sclerosing cholangitis, HIV, or prior documentation of NAFLD.
3. Patients on medications known to cause fatty liver disease: tamoxifen, corticosteroids, amiodarone, methotrexate, valproic acid
4. Patients carrying an implantable active medical device such as a pacemaker or a defibrillator
5. Pregnant women
Phase II:
1. CCTA/CAC only: GFR \<60 mls/min/1.73m2 or IV contrast dye allergy
2. CCTA/CAC only: contraindications to atrioventricular (AV) nodal blocking agents (high degree AV block without permanent pacemaker, asthma, allergy to nodal blocking agents).
3. Known CAD defined as previous PCI or CABG (Note: Subjects with CCTA within the past 12 months will not be excluded from study and repeat scan will not be needed but the results of that previous scan will be included in the prevalence and severity analysis.)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT03142867
Study Brief:
Protocol Section:
NCT03142867