RECRUITING

The Effect of Mindfulness on Vascular Inflammation in Stable Coronary Disease

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Conditions

AtherosclerosisStressInflammation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-11-01
Study Completion:2026-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04505865

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:45 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Must admit to feeling stressed and/or have PSS score \> 13 (moderate stress)
  2. * Must be willing to complete stress reduction course and imaging sessions with \< 3 missed appointments in last year
  3. * 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
  4. * Stable symptoms without symptomatic heart failure or arrhythmia or planned revascularization
  5. * Maximally tolerated and stable medical regimen for 90 days that does not include a high intensity statin for clinical reasons
  6. * No neurological disease or systemic inflammatory disease/current anti-inflammatory therapy
  7. * No active psychiatric disease/medications or substance abuse (including tobacco smoking or more than moderate alcohol) for last 6 months
  8. * No current participation in cardiac rehab or prior participation in stress reduction
  9. * For imaging: no pregnancy, weight \> 300 lbs., metal implants, uncontrolled hyperglycemia, or inability to provide consent or comply
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Michael T Osborne, MD
CONTACT
6176432114
mosborne@mgh.harvard.edu

Principal Investigator

Michael T Osborne, MD
PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital

Study Locations (Sites)

Massachusetts General Hospital
Boston, Massachusetts, 02114
United States

Collaborators and Investigators

Sponsor: Massachusetts General Hospital

  • Michael T Osborne, MD, PRINCIPAL_INVESTIGATOR, Massachusetts General Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-11-01
Study Completion Date2026-10

Study Record Updates

Study Start Date2021-11-01
Study Completion Date2026-10

Terms related to this study

Additional Relevant MeSH Terms

  • Atherosclerosis
  • Stress
  • Inflammation