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 @ 1:06 AM
Ignite Modification Date:
2025-12-25 @ 1:06 AM
NCT ID:
NCT03041493
Eligibility Criteria:
Inclusion Criteria:
* Male or female between 18 and 50 years of age.
* Good general health with no history of diabetes, coronary artery disease, peripheral arterial disease, chronic disease or hypertension.
* Ability to sign an informed consent.
Tobacco product users will have additional inclusion criteria:
* For TC smokers, daily TC smoking in the past 6 months, at least 10 cigarettes per day, with no EC exposure in the past 6 months
* For EC users, daily EC use in the past 6 months, at least 10 sessions per day, with no TC exposure in the past 6 month
* For non-smokers, no significant lifetime exposure to any nicotine-containing product, where significant exposure is defined as daily use of any nicotine-containing product for more than one week or once monthly use for more than 6 months.
Exclusion Criteria:
* History of renal disease, hypertension, diabetes, congestive heart failure or emphysema
* Use of ACE inhibitors, Angiotensin II receptor blockers, diuretics, aldosterone, renin blockers, aspirin, statins, sildenafil (or other PDE5 inhibitors) and NSAIDs.
* History of substance abuse
* Currently using nicotine replacement or other tobacco cessation products or intentionally abstaining from nicotine-containing products
* IV contrast exposure in the past 1 month
* Inability to place an IV catheter or draw blood for any reason
* Pregnant women or breastfeeding
* Potential subjects will be asked if they are pregnant. Verbal confirmation of pregnancy will be sufficient.
* Fever of \>101°F or BP \>180/95
* BMI ≥30
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT03041493
Study Brief:
Protocol Section:
NCT03041493