Heart Disease Trial, Recruiting NCT04505865 Sponsor: Massachusetts General Hospital Condition: Heart Disease
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Heart Disease Trial, Recruiting

NCT04505865
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who report feeling stressed, or who score above 13 on a standard stress measurement scale (indicating moderate stress)
  • People who are willing to complete a stress reduction course and attend imaging sessions, with fewer than 3 missed appointments in the past year
  • People who have a known history of heart disease, such as a previous heart attack, a procedure to open blocked arteries, or bypass surgery that took place more than 6 months ago — or who have been found to have significant calcium buildup in the arteries of the heart on a scan
  • People whose heart condition is currently stable, with no active heart failure, irregular heart rhythms, or planned procedures to restore blood flow to the heart
  • People who have been on a stable, maximum tolerated heart medication routine for at least 90 days, and whose doctor has determined that a high-intensity cholesterol-lowering medication (high-intensity statin) is not appropriate for them for medical reasons

Who may not be able to join:

  • People who have a neurological condition or a disease that causes widespread inflammation in the body, or who are currently taking anti-inflammatory medications
  • People who have an active psychiatric (mental health) condition, are taking psychiatric medications, or have had issues with substance use — including tobacco smoking or more than moderate alcohol use — in the past 6 months
  • People who are currently taking part in cardiac rehabilitation or who have previously participated in a formal stress reduction program
  • People who are pregnant, weigh more than 300 pounds, have certain metal implants in their body, have poorly controlled blood sugar levels, or are unable to give consent or follow the study requirements (these criteria apply specifically to the imaging portion of the trial)

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 16 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Michael T Osborne, MD, Massachusetts General Hospital

Phone: 6176432114

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Registry
ClinicalTrials.gov
Start date
1 November 2021
Est. completion
1 December 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Change in arterial inflammation by PET imaging

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 16 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov