Clinical trial NCT04505865: The Effect of Mindfulness on Vascular Inflammation in Stable Coronary Disease
Official title: The Effect of Mindfulness on Vascular Inflammation in Stable Coronary Disease: A Multi-System PET/MRI Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Atherosclerosis
Stress
Inflammation
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2020-08-10
Enrollment: 36
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 emission tomography (PET) with 18F-fluorodeoxyglucose (FDG) in individuals with increased psychosocial stress.

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-identified high levels of stress and stable coronary artery disease. Individuals will undergo baseline FDG-PET and magnetic resonance imaging (MRI) and will then be randomized to the stress-reduction intervention group or no intervention groups by blocks (1:1) with stratification by age and sex. The stress reduction sessions focus on developing an understanding of stress physiology and the physiology of the relaxation response, on developing a regular practice of eliciting the relaxation response, and on learning cognitive behavioral and positive psychology/resilience skills.

During the screening period, patient acceptability for the study will be assessed based on medical history, concomitant medications, physical examination, and clinical laboratory test results. Acceptability for study participation will be confirmed for subjects who identify as having increased levels of stress and/or a Perceived Stress Scale (PSS) score \>=14. Once the patient has passed screening, they will undergo baseline imaging followed by randomization and group assignment. Approximately 12 weeks after randomization, all individuals will return for follow-up imaging and evaluation.

FDG PET/MRI scans will be performed during the study for baseline and follow up to assess the intervention's impact on the brain as well as systemic and arterial inflammation along with other changes in related biomarker and imaging parameters. The Perceived Stress Scale will be delivered prior imaging during both imaging visits to measure perceived psychological stress. During both imaging sessions, subjects will be exposed to overt faces to measure signals during brain imaging.

Eligibility 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

Primary outcomes:
measure: Change in arterial inflammation by PET imaging
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in brain activity by PET
timeFrame: 12 weeks
measure: Change in bone marrow activity by PET
timeFrame: 12 weeks
measure: Change in inflammatory biomarkers
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Michael T Osborne, MD
role: PRINCIPAL_INVESTIGATOR
References: