The Effect of Mindfulness on Vascular Inflammation in Stable Coronary Disease
Primary Purpose
Atherosclerosis, Stress, Inflammation
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Stress Reduction
Sponsored by
About this trial
This is an interventional treatment trial for Atherosclerosis
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
- 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
Sites / Locations
- Massachusetts General HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Usual care
Stress reduction
Arm Description
Optimally tolerated medical therapy
Optimally tolerated medical therapy and stress reduction course for 8 weeks
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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
Change in inflammatory biomarkers
Change in high-sensitivity C-reactive protein (mg/L)- from initial imaging to repeat imaging
Full Information
NCT ID
NCT04505865
First Posted
August 5, 2020
Last Updated
March 13, 2023
Sponsor
Massachusetts General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04505865
Brief Title
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
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
January 2026 (Anticipated)
Study Completion Date
October 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atherosclerosis, Stress, Inflammation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
36 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
Optimally tolerated medical therapy
Arm Title
Stress reduction
Arm Type
Experimental
Arm Description
Optimally tolerated medical therapy and stress reduction course for 8 weeks
Intervention Type
Behavioral
Intervention Name(s)
Stress Reduction
Other Intervention Name(s)
SMART-3RP
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in arterial inflammation by PET imaging
Description
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
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change in brain activity by PET
Description
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
Time Frame
12 weeks
Title
Change in bone marrow activity by PET
Description
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
Time Frame
12 weeks
Title
Change in inflammatory biomarkers
Description
Change in high-sensitivity C-reactive protein (mg/L)- from initial imaging to repeat imaging
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael T Osborne, MD
Phone
6176432114
Email
mosborne@mgh.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael T Osborne, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Osborne, MD
Email
mosborne@mgh.harvard.edu
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
The Effect of Mindfulness on Vascular Inflammation in Stable Coronary Disease
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