NCT04505865Recruiting
The Effect of Mindfulness on Vascular Inflammation in Stable Coronary Disease
The Effect of Mindfulness on Vascular Inflammation in Stable Coronary Disease: A Multi-System PET/MRI Study
Source: ClinicalTrials.gov · Last updated 19 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 36 (estimated)
- First submitted
- 5 Aug 2020
- Start date
- 1 Nov 2021
- Primary completion date
- 1 Dec 2026
- Lead sponsor
- Massachusetts General Hospital
- Diseases
- Coronary artery disease
- NCT number
- NCT04505865
What you commit to
- Study type: Interventional
- Planned participants: 36
- From 1 Nov 2021 to the primary completion date, 1 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Who the study is looking for
- 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
Age in the registry: 45 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.