Mindfulness intervention for reducing vascular inflammation in coronary disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the impact of an 8-week mindfulness-based stress reduction program on vascular inflammation in adults with stable coronary artery disease. Participants with high levels of psychosocial stress will undergo baseline imaging using FDG-PET and MRI, followed by randomization into either the intervention or control group. The intervention focuses on stress physiology, relaxation techniques, and cognitive behavioral skills. After 12 weeks, follow-up imaging will assess changes in arterial inflammation.

Why it matters

Who can join: the full rules

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

Where it's running

• Massachusetts General Hospital
  Boston, Massachusetts, United States Recruiting

Study contacts

• Principal investigator: Michael T Osborne, MD — Massachusetts General Hospital
• Study coordinator: Michael T Osborne, MD
• Email: mosborne@mgh.harvard.edu
• Phone: 6176432114

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.