RecruitingNot ApplicableNCT04505865

The Effect of Mindfulness on Vascular Inflammation in Stable Coronary Disease

The Effect of Mindfulness on Vascular Inflammation in Stable Coronary Disease: A Multi-System PET/MRI Study


Sponsor

Massachusetts General Hospital

Enrollment

36 participants

Start Date

Nov 1, 2021

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 45 YearsMax Age: 65 Years

Inclusion Criteria9

  • 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

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Interventions

BEHAVIORALStress Reduction

The stress reduction program is a multimodal mind-body resiliency program that incorporates 3 core components into each session: 1\) Elicitation of the Relaxation Response through mind-body techniques; 2) discussion about stress awareness to learn how to identify personal stressors and experiences of stress; and 3) coping strategies and adaptive perspective-taking to promote positive well-being.


Locations(1)

Massachusetts General Hospital

Boston, Massachusetts, United States

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NCT04505865


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