The Effect of Mindfulness on Vascular Inflammation in Stable Coronary Disease

NCT04505865 | Recruiting

• 1 other identifier: 2020A002750
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Atherosclerosis; Stress; Inflammation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in brain activity by PET

  12 weeks

• Change in bone marrow activity by PET

  12 weeks

• Change in inflammatory biomarkers

  12 weeks

Study Arms (2)

Usual care

NO INTERVENTION

Optimally tolerated medical therapy

Stress reduction

EXPERIMENTAL

Optimally tolerated medical therapy and stress reduction course for 8 weeks

Behavioral: Stress Reduction

Interventions

Stress Reduction BEHAVIORAL

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.

Also known as: SMART-3RP

Stress reduction

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

MeSH Terms

Conditions

Atherosclerosis; Inflammation

Interventions

Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Michael T Osborne, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael T Osborne, MD

CONTACT

6176432114; mosborne@mgh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor of Medicine

Study Record Dates

• First Submitted: August 5, 2020
• First Posted: August 10, 2020
• Study Start: November 1, 2021
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

US (1)