Actively Recruiting

Phase Not Applicable
Age: 45Years - 65Years
All Genders
NCT04505865

The Effect of Mindfulness on Vascular Inflammation in Stable Coronary Disease

Led by Massachusetts General Hospital · Updated on 2026-03-19

36

Participants Needed

1

Research Sites

269 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

The Effect of Mindfulness on Vascular Inflammation in Stable Coronary Disease

Who Can Participate

Age: 45Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

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
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

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Trial Site Locations

Total: 1 location

1

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Actively Recruiting

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Research Team

M

Michael T Osborne, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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