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Mindfulness for Vascular Inflammation in Coronary Artery Disease

This study is looking at how a stress reduction program, which includes mindfulness and other mind-body techniques, affects inflammation in the arteries of people with stable coronary artery disease (a condition where arteries narrow due to plaque buildup). Researchers want to see if this program can reduce arterial inflammation, which is measured using a special PET scan. You might be able to join if you are between 45 and 65 years old, feel stressed, and have a history of heart disease. The study aims to enroll 36 participants, but its current recruitment status is unclear.

Study design
This is a randomized study, meaning participants will be assigned by chance to either the stress reduction program or a group that receives no intervention. It plans to enroll 36 participants.
What's involved
You would undergo baseline imaging (PET and MRI scans), participate in an 8-week stress reduction course, and then have follow-up imaging about 12 weeks after randomization.
Compensation
Not stated in the trial record.
Follow-up
Participants will have follow-up imaging and evaluation approximately 12 weeks after randomization.

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NCT04505865

The Effect of Mindfulness on Vascular Inflammation in Stable Coronary Disease

Recruiting
NAAges 45–65InterventionalTreatment
Massachusetts General Hospital
~36 participants
Updated 2026-03-19 on ClinicalTrials.gov
What's tested:Stress Reduction

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in arterial inflammation by PET imaging
Measured over 12 weeks

Conditions

Atherosclerosis
Stress
Inflammation

Explore related trials

Atherosclerosis

Where it's being run

1 sites across 1 states
Massachusetts1

Study leadership

  • Michael T Osborne, MD · PRINCIPAL_INVESTIGATOR · Massachusetts General Hospital

Who to contact

Michael T Osborne, MD
[email protected]
6176432114
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

What this trial measures

  • Change in arterial inflammation by PET imaging12 weeks

    Change in arterial inflammation measured as the ratio of tracer activity in the walls of the aorta and carotid arteries to the activity of background venous blood on FDG PET imaging (ratio without units) - from initial imaging to repeat imaging