Status:
RECRUITING
The Effect of Mindfulness on Vascular Inflammation in Stable Coronary Disease
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Atherosclerosis
Stress
Eligibility:
All Genders
45-65 years
Phase:
NA
Brief 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 emi...
Detailed Description
This randomized controlled imaging study will be performed to evaluate the impact of mindfulness-based stress reduction via a mind body program on arterial inflammation in individuals with self-identi...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
November 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT04505865
Start Date
November 1 2021
End Date
December 31 2026
Last Update
December 16 2024
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114