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 @ 9:28 PM
Ignite Modification Date:
2025-12-24 @ 9:28 PM
NCT ID:
NCT07260032
Eligibility Criteria:
Inclusion Criteria:
* Age 18-65 years
* Trauma exposure
* PTSD symptoms
* Subclinical atherosclerotic CVD (e.g., coronary, cerebrovascular, or peripheral arterial plaque or calcifications on imaging), clinical atherosclerotic CVD (e.g., myocardial infarction or revascularization), or increased risk for atherosclerotic CVD (i.e., \>2 of hypertension, diabetes mellitus, hyperlipidemia, and active smoking)
* Ability to understand and sign informed consent
Exclusion Criteria:
* History of stroke, brain surgery, or seizure
* Use of certain CVD medications (e.g., beta-blockers, high-intensity statins \[e.g., rosuvastatin 20/40 mg and atorvastatin 40/80 mg\], PCSK-9 inhibitors)
* Psychiatric or cardiovascular medication change within 4 weeks (i.e., stable regimen is allowed)
* Unstable blood pressure or cardiac arrhythmia
* Currently in a supervised or graduated exercise program
* Neurological or systemic inflammatory disease/current systemic anti-inflammatory therapy
* Moderate/severe alcohol/substance use disorder
* Current mania/psychosis
* Weight \>300 lbs.
* Claustrophobia
* Pregnancy
* Metal implants
* Uncontrolled hyperglycemia (HgbA1c\>7.5%)
* Subjects who have had significant radiation exposure as part of research (\>2 nuclear tests, computed tomography images, or fluoroscopic procedures) during the preceding 12-months
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT07260032
Study Brief:
Protocol Section:
NCT07260032