Using Advanced Imaging to Determine the Benefits of Exercise on Cardiovascular Risk in PTSD
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Heart rate
Study Overview
Brief Summary
The purpose of this study is to use a non-invasive imaging technique called positron emission tomography/magnetic resonance imaging (PET/MRI) to investigate the effects of exercise on brain activity and arterial (blood vessel) inflammation in people with PTSD symptoms and evidence of or elevated risk for artery disease.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Heart rate
Time Frame: Pre-treatment; Post-treatment (12-16 weeks after pre-treatment visit)
10-minute resting heart rate will be measured in beats per minute and collected from electrocardiogram (ECG)
Blood pressure
Time Frame: Pre-treatment; Post-treatment (12-16 weeks after pre-treatment visit)
Systolic and diastolic blood pressure
Heart rate variability
Time Frame: Pre-treatment; Post-treatment (12-16 weeks after pre-treatment visit)
10-minute resting heart rate variability will be measured using heart rate R-peak interval times collected from electrocardiogram (ECG)
Arterial inflammation
Time Frame: Pre-treatment; Post-treatment (12-16 weeks after pre-treatment visit)
Aortic and carotid arterial inflammation will be based on uptake of 18F-fluorodeoxyglucose during positron emission tomography in these sites
Bone marrow inflammation
Time Frame: Pre-treatment; Post-treatment (12-16 weeks after pre-treatment visit)
Bone marrow inflammation will be based on uptake of 18F-fluorodeoxyglucose during positron emission tomography
Secondary Outcomes
No secondary outcomes reported
Investigators
Antonia V. Seligowski, PhD
Assistant Professor
Massachusetts General Hospital