The Effect of Mindfulness on Vascular Inflammation in Stable Coronary Disease

Inflammation Clinical Trial

Official title:

The Effect of Mindfulness on Vascular Inflammation in Stable Coronary Disease: A Multi-System PET/MRI Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04505865
• Other study ID #: 2020A002750
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: October 2026

Study information

• Verified date: December 2023
• Source: Massachusetts General Hospital
• Contact: Michael T Osborne, MD
• Phone: 6176432114
• Email: mosborne[@]mgh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: October 2026
• Est. primary completion date: January 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Atherosclerosis
• Coronary Artery Disease
• Coronary Disease
• Inflammation
• Stress

Intervention

Behavioral:
• Stress Reduction
The stress reduction program is a multimodal mind-body resiliency program that incorporates 3 core components into each session: 1) Elicitation of the Relaxation Response through mind-body techniques; 2) discussion about stress awareness to learn how to identify personal stressors and experiences of stress; and 3) coping strategies and adaptive perspective-taking to promote positive well-being.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in arterial inflammation by PET imaging	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	12 weeks
Secondary	Change in brain activity by PET	Change in brain activity ratio of tracer activity in the amygdala (a stress-associated brain center) to the activity of background brain cortical tissue on FDG PET imaging (ratio without units) based on FDG PET - from initial imaging to repeat imaging	12 weeks
Secondary	Change in bone marrow activity by PET	Change in bone marrow activity measured in the vertebral bodies as a mean standardized uptake value (g/mL) based on FDG PET - from initial imaging to repeat imaging	12 weeks
Secondary	Change in inflammatory biomarkers	Change in high-sensitivity C-reactive protein (mg/L)- from initial imaging to repeat imaging	12 weeks