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 @ 1:22 AM
Ignite Modification Date:
2025-12-25 @ 1:22 AM
NCT ID:
NCT06429293
Eligibility Criteria:
Inclusion Criteria:
* age 18-65 years (upper limit chosen to optimize changes in brain activation that diminish with age);
* criterion A trauma exposure and PTSD symptoms (clinically significant symptoms in at least two symptom clusters);
* 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
* fluent English speaker.
Exclusion Criteria:
* history of stroke, brain surgery, 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);
* currently in PTSD therapy;
* neurological or systemic inflammatory disease/current anti-inflammatory therapy;
* moderate/severe alcohol/substance use disorder;
* current mania/psychosis;
* weight \>300 lbs., claustrophobia, pregnancy, metal implants that are incompatible with magnetic resonance imaging (MRI), or uncontrolled hyperglycemia (for imaging);
* significant radiation exposure (\>2 nuclear tests, computed tomography images, or fluoroscopic procedures) for research purposes during the preceding 12-months.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT06429293
Study Brief:
Protocol Section:
NCT06429293