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Mindfulness for Coronary Artery Disease

N/A
Recruiting
Led By Michael T Osborne, MD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Stable symptoms without symptomatic heart failure or arrhythmia or planned revascularization
No neurological disease or systemic inflammatory disease/current anti-inflammatory therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights

Summary

This trial will study the effects of stress reduction on plaque inflammation in people with stable coronary artery disease.

Who is the study for?
This trial is for adults with stable coronary artery disease who have had a heart issue like a heart attack or surgery over 6 months ago. They should feel stressed, not be in cardiac rehab or stress reduction programs, and must commit to the course and imaging sessions. Participants can't join if they're pregnant, very overweight, have metal implants, uncontrolled diabetes, serious mental health issues or substance abuse problems.
What is being tested?
The study tests whether an 8-week stress reduction program can lower inflammation in blood vessels of the heart as seen on special PET scans using FDG in people with stable coronary artery disease who are also experiencing high levels of stress.
What are the potential side effects?
Since this trial involves mindfulness and stress reduction techniques rather than medication, side effects may include temporary discomfort during relaxation exercises but no significant medical side effects are expected.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My heart condition is stable with no symptoms of failure or irregular heartbeat.
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I do not have any neurological or systemic inflammatory diseases, nor am I on anti-inflammatory therapy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in arterial inflammation by PET imaging
Secondary study objectives
Change in bone marrow activity by PET
Body Weight Changes
Change in inflammatory biomarkers

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Stress reductionExperimental Treatment1 Intervention
Optimally tolerated medical therapy and stress reduction course for 8 weeks
Group II: Usual careActive Control1 Intervention
Optimally tolerated medical therapy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Stress Reduction
2019
Completed Phase 3
~350

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
2,993 Previous Clinical Trials
13,230,685 Total Patients Enrolled
27 Trials studying Inflammation
2,226 Patients Enrolled for Inflammation
Michael T Osborne, MDPrincipal InvestigatorMassachusetts General Hospital

Media Library

Stress Reduction Clinical Trial Eligibility Overview. Trial Name: NCT04505865 — N/A
Inflammation Research Study Groups: Usual care, Stress reduction
Inflammation Clinical Trial 2023: Stress Reduction Highlights & Side Effects. Trial Name: NCT04505865 — N/A
Stress Reduction 2023 Treatment Timeline for Medical Study. Trial Name: NCT04505865 — N/A
~11 spots leftby Jan 2026
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