Mindfulness intervention for reducing vascular inflammation in coronary disease
The Effect of Mindfulness on Vascular Inflammation in Stable Coronary Disease: A Multi-System PET/MRI Study
This study tests if an 8-week mindfulness program can help reduce inflammation in the blood vessels of adults with stable coronary artery disease who are dealing with high stress.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 45 Years to 65 Years |
| Sex | All |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT04505865 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults with stable coronary artery disease who report high levels of stress.
Not a fit: Patients with active psychiatric disorders, systemic inflammatory diseases, or those currently participating in cardiac rehabilitation may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could reduce vascular inflammation and improve cardiovascular health in patients with coronary artery disease.
How similar studies have performed: Previous studies have shown promising results for mindfulness interventions in reducing stress and improving health outcomes, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Boston, Massachusetts
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.