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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 45
Maximum Age: 65
Healthy Volunteers: f
View:

• 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

Locations
United States
Massachusetts
Massachusetts General Hospital
RECRUITING
Boston
Contact Information
Primary
Michael T Osborne, MD
mosborne@mgh.harvard.edu
6176432114
Time Frame
Start Date: 2021-11-01
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 36
Treatments
No_intervention: Usual care
Optimally tolerated medical therapy
Experimental: Stress reduction
Optimally tolerated medical therapy and stress reduction course for 8 weeks
Related Therapeutic Areas
Sponsors
Leads: Massachusetts General Hospital

This content was sourced from clinicaltrials.gov