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 @ 3:54 PM
Ignite Modification Date:
2025-12-24 @ 3:54 PM
NCT ID:
NCT01282892
Eligibility Criteria:
Inclusion Criteria:
* excess of visceral fat with the major cardiovascular risk factors for coronary CT,
* diagnosis of fatty liver defined by the presence of bright liver echo pattern, absence of alcohol use (\<20g/day),
* negative serology for hepatitis B or C diagnosis,
* negative auto antibodies,
* absence of history of another known liver disease,
* 30 sex-age-matched individual with cardiovascular risk factors and without NAFLD and without visceral fat will be considered as controls.
* Informed consent will be obtained from each individual and the study will be presented to the the local ethics committee.
Exclusion Criteria:
* subjects with severe obesity (BMI\>35),
* recent history of acute illness,
* clinical history of ischemic heart disease and cerebro vascular disease,
* typical chest pain,
* previous coronary artery disease,
* conventional coronary angiography,
* percutaneous interventions,
* coronary by pass grafting,
* renal failure,
* cancer patients,
* subjects who take drugs that induces hepatic steatosis ( corticosteroids, estrogens, methotrexate, amiodarone and others).
* Exclusion criteria for coronary computed tomography angiography will included also the presence of multiple ectopic beats, atrial fibrillation, heart rate more than 75/min despite therapy, severe lung disease, or a history of allergic reaction to iodine-containing contrast agents.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
70 Years
Study:
NCT01282892
Study Brief:
Protocol Section:
NCT01282892