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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

Study 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.Check my eligibility

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.See study design

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

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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in arterial inflammation by PET imaging

Secondary outcome measures

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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor

2,933 Previous Clinical Trials

13,198,445 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this trial welcoming participants aged 45 and over?

"The requirements for participation in this medical trial mandate that patients must be between the ages of 50 and 65. For those younger than 18, there are 70 relevant studies; however, anyone over the age of 65 can find 997 trials to consider."

Answered by AI

What is the utmost capacity for subjects in this clinical trial?

"Affirmative. According to the info on clinicaltrials.gov, this scientific trial is actively recruiting participants with a start date of November 1st 2021 and most recent update being October 17th 2022. 36 individuals are needed from a single site for full enrollment in the study."

Answered by AI

Am I eligible to join the research project?

"This medical research study seeks 36 participants aged between 50 and 65 who have atherogenesis. Additionally, enrollees must not be diagnosed with any active psychiatric or neurological diseases, abstain from substance abuse for the past 6 months, demonstrate moderate stress levels (PSS score > 13), consent to complete a stress reduction course as well as imaging sessions without more than 3 missed appointments in one year, possess known clinical cardiovascular disease with prior arterial occlusion history of at least 6 months duration that does not include high-intensity statin therapy due to medical reasons, not participate in cardiac rehabilitation nor already completed stress management programing; meet non-"

Answered by AI

Are enrollment applications for this experiment still being considered?

"According to clinicaltrials.gov, the recruitment process for this medical trial is still ongoing. The initial posting was on November 1st 2021 and it has been updated most recently on October 17th 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The Effect of Mindfulness on Vascular Inflammation in Stable Coronary Disease

Michael T. Osborne 2021. "The Effect of Mindfulness on Vascular Inflammation in Stable Coronary Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04505865.

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