The Effect of Mindfulness on Vascular Inflammation in Stable Coronary Disease
Recruiting now · Not applicable
Conditions studied: Atherosclerosis, Stress, Inflammation
In brief
This study aims to evaluate the effect of 8 weeks of a stress reduction intervention on atherosclerotic plaque inflammation in adults with stable coronary artery disease, as quantified by positron emission tomography (PET) with 18F-fluorodeoxyglucose (FDG) in individuals with increased psychosocial stress.
Key facts
- Study ID
- NCT04505865
- Run by
- Massachusetts General Hospital
- People needed
- 36
- Starts
- 2021-11-01
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2026-03-19
Who can join
Age: 45 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Must admit to feeling stressed and/or have PSS score > 13 (moderate stress)
- Must be willing to complete stress reduction course and imaging sessions with < 3 missed appointments in last year
- Known clinical cardiovascular disease with prior atherosclerotic myocardial infarction, percutaneous intervention or bypass surgery > 6 months before entry, or severe coronary calcifications on computed tomography or coronary calcium score >400
- Stable symptoms without symptomatic heart failure or arrhythmia or planned revascularization
- Maximally tolerated and stable medical regimen for 90 days that does not include a high intensity statin for clinical reasons
- No neurological disease or systemic inflammatory disease/current anti-inflammatory therapy
- No active psychiatric disease/medications or substance abuse (including tobacco smoking or more than moderate alcohol) for last 6 months
- No current participation in cardiac rehab or prior participation in stress reduction
- For imaging: no pregnancy, weight > 300 lbs., metal implants, uncontrolled hyperglycemia, or inability to provide consent or comply
Where it is running
- Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
Full record on ClinicalTrials.gov
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