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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.
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.
Awards & highlights

cfDNA in CS Trial 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.Check my eligibility
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.See study design
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.

cfDNA in CS Trial 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.

cfDNA in CS Trial 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.
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.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
cfDNA level

cfDNA in CS Trial Design

4Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Sarcoidosis patients with evidence of active myocarditisExperimental Treatment1 Intervention
Two blood draws 2 months apart.
Group II: Sarcoidosis patients without evidence of active myocarditisActive Control1 Intervention
A single blood draw.
Group III: Acute ST elevation myocardial infarction (STEMI)Active Control1 Intervention
Three blood draws, baseline, 6 hours and 24 hours.
Group IV: Healthy controlsPlacebo Group1 Intervention
A single blood draw

Find a Location

Who is running the clinical trial?

Nabeel HamzehLead Sponsor
1 Previous Clinical Trials
21 Total Patients Enrolled
Nabeel Hamzeh, MDPrincipal Investigator - University of Iowa
Iowa City VA Medical Center
University Of Jordan (Medical School)
Baylor College Of Medicine (Residency)
2 Previous Clinical Trials
38 Total Patients Enrolled
1 Trials studying Sarcoidosis
17 Patients Enrolled for Sarcoidosis

Media Library

cell free DNA Clinical Trial Eligibility Overview. Trial Name: NCT03858777 — N/A
Sarcoidosis Research Study Groups: Sarcoidosis patients without evidence of active myocarditis, Sarcoidosis patients with evidence of active myocarditis, Healthy controls, Acute ST elevation myocardial infarction (STEMI)
Sarcoidosis Clinical Trial 2023: cell free DNA Highlights & Side Effects. Trial Name: NCT03858777 — N/A
cell free DNA 2023 Treatment Timeline for Medical Study. Trial Name: NCT03858777 — N/A
Sarcoidosis Patient Testimony for trial: Trial Name: NCT03858777 — N/A

Frequently Asked Questions

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

Is participation in this clinical experiment still available to the public?

"Affirmative. Clinicaltrials.gov has documented that the trial, initially posted on May 1st 2019, is actively enrolling 120 people from a single site. It was most recently updated on May 16th 2022."

Answered by AI

How many participants have been recruited for this experiment?

"Affirmative. Information located on clinicaltrials.gov suggests that, after being first posted on the 1st of May 2019 and recently updated in 16th of May 2022, this research is actively seeking 120 participants from a single medical site."

Answered by AI

Who else is applying?

What state do they live in?
Illinois
Iowa
What site did they apply to?
University of Iowa
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
2

Why did patients apply to this trial?

I;ve tried (2) other drugs in the past with very limited positive results.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Cell Free DNA in Cardiac Sarcoidosis
Nabeel Hamzeh 2019. "Cell Free DNA in Cardiac Sarcoidosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03858777.
All > Heart Attack > Sarcoidosis
~29 spots leftby Dec 2025
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