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The Effect of Mindfulness on Vascular Inflammation in Stable Coronary Disease
RECRUITINGN/ASponsored by Massachusetts General Hospital
Actively Recruiting
PhaseN/A
SponsorMassachusetts General Hospital
Started2021-11-01
Est. completion2026-02-28
Eligibility
Age45 Years – 65 Years
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →
NCT04505865
Summary
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.
Eligibility
Age: 45 Years – 65 YearsHealthy volunteers accepted
Inclusion Criteria: * 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
Conditions4
AtherosclerosisHeart DiseaseInflammationStress
Locations1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
Michael Osborne, MDmosborne@mgh.harvard.edu
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Actively Recruiting
PhaseN/A
SponsorMassachusetts General Hospital
Started2021-11-01
Est. completion2026-02-28
Eligibility
Age45 Years – 65 Years
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →
NCT04505865