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Cell Free DNA Testing for Myocarditis (cfDNA in CS Trial)

N/A

Recruiting

Led By Nabeel Hamzeh, MD

Research Sponsored by Nabeel Hamzeh

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Healthy controls: No known cardiac disease

Undergoing cardiac intervention for acute coronary syndrome.

Must not have

Acute ST elevation myocardial infarction (STEMI): Hemodynamically unstable

Sarcoidosis patients without evidence of active myocarditis: Active smoker

Timeline

Screening 3 weeks

Treatment Varies

Follow Up cfdna level at baseline and 2 months for sarcoidosis with heart disease compared to cfdna levels at baseline for healthy controls and sarcoidosis without cardiac disease and cfdna levels at baseline, 6 and 24 hours for stemi patients.

Summary

This trial is looking at a potential new way to diagnose active myocarditis (inflammation of the heart) in patients with sarcoidosis. The current method for diagnosing active myocarditis is limited and this trial is exploring whether cell free DNA (fragments of genomic DNA that are released into the circulation from dying or damaged cells) can be used as a biomarker to more accurately diagnose active myocarditis.

Who is the study for?

This trial is for non-smokers with sarcoidosis diagnosed by ATS/ERS criteria, experiencing active myocarditis confirmed by cMRI or cFDG-PET. It includes those undergoing cardiac intervention for acute coronary syndrome (STEMI) and healthy controls without cardiovascular risks or known cardiac disease. Excluded are smokers, those on immunosuppressive therapy, hemodynamically unstable patients, and anyone with other known cardiac diseases.

What is being tested?

The study tests the use of cell free DNA (cfDNA) as a diagnostic tool to identify granulomatous myocarditis in sarcoidosis patients. The goal is to find a specific biomarker that can guide treatment decisions and monitor response to therapy without the need for high-radiation imaging techniques like FDG-PET.

What are the potential side effects?

Since this trial focuses on using cfDNA as a diagnostic tool rather than a therapeutic intervention, it does not directly involve treatments that would cause side effects typically associated with medications or procedures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have no known heart diseases.

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I am receiving treatment for a sudden heart problem.

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I have been diagnosed with sarcoidosis but do not have active heart inflammation.

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I have been diagnosed with sarcoidosis by a doctor.

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I have been diagnosed with a severe type of heart attack.

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I am receiving treatment for a recent severe heart attack.

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I have sarcoidosis without heart inflammation and haven't taken immunosuppressants for a year.

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I have sarcoidosis with heart inflammation, diagnosed by specific criteria.

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I had a heart attack with specific EKG changes within the last 12 hours.

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I do not have hypertension or diabetes.

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I have sarcoidosis with active heart inflammation confirmed by a recent heart scan.

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I do not have any heart diseases.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I had a severe heart attack and am currently unstable.

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I have sarcoidosis without heart inflammation and I currently smoke.

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I am currently a smoker and have had a recent heart attack.

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I have sarcoidosis with active heart inflammation and I currently smoke.

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I have sarcoidosis but no active heart inflammation and am on immunosuppressive therapy.

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I have sarcoidosis with active heart inflammation and no other heart conditions.

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I have sarcoidosis but no active heart inflammation, and I have a known heart condition.

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I have sarcoidosis with active heart inflammation and am on immunosuppressive medication.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ cfdna level at baseline and 2 months for sarcoidosis with heart disease compared to cfdna levels at baseline for healthy controls and sarcoidosis without cardiac disease and cfdna levels at baseline, 6 and 24 hours for stemi patients.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~cfdna level at baseline and 2 months for sarcoidosis with heart disease compared to cfdna levels at baseline for healthy controls and sarcoidosis without cardiac disease and cfdna levels at baseline, 6 and 24 hours for stemi patients.

This trial's timeline: 3 weeks for screening, Varies for treatment, and cfdna level at baseline and 2 months for sarcoidosis with heart disease compared to cfdna levels at baseline for healthy controls and sarcoidosis without cardiac disease and cfdna levels at baseline, 6 and 24 hours for stemi patients. for reporting.