Cardiomyocyte Specific Cell Free DNA as a Marker of Cardiac Sarcoidosis

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Sarcoidosis is a multisystem granulomatous disease of unknown cause that can affect any organ in the body, including the heart. Granulomatous myocarditis can lead to ventricular dysfunction and ventricular arrhythmias causing significant morbidity and mortality. Immunosuppressive therapy (IST) has been shown to reverse active myocarditis and preserve left ventricular (LV) function and in some cases improve LV function. In addition, IST can suppress arrhythmias that develop due to active myocarditis and prevent the formation of scar. The potential role of cardiac biomarkers, including brain natriuretic peptide (BNP), atrial natriuretic peptide (ANP), and cardiac troponins, in detecting active myocarditis is limited and studies have been disappointing. At present, there are no biomarkers to detect active myocarditis and the use of advanced imaging modalities (FDG-PET) for assessing and monitoring active myocarditis is not feasible or practical and is associate with high radiation exposure. As such, a biomarker that is reflective of active myocarditis and that is cardiac specific will assist physicians in assessing the presence of active myocarditis to guide therapeutic decisions and to assess response to therapy which can limit further cardiac damage. Cell free DNA (cfDNA) are fragments of genomic DNA that are released into the circulation from dying or damaged cells. It is a powerful diagnostic tool in cancer, transplant rejection and fetal medicine especially when the genomic source differs from the host. A novel technique that relies on tissue unique CpG methylation patterns can identify the tissue source of cell free DNA in an individual reflecting potential tissue injury. We will be conducting a pilot study to explore the utility of this diagnostic tool to identify granulomatous myocarditis in patients with sarcoidosis.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

⁃ Diagnosis of sarcoidosis based on the ATS/ERS criteria.

• Normal 12 lead ECG within the past one year.

• Non-smoker.

• No immunosuppressive therapy for at least one year.

⁃ Diagnosis of sarcoidosis based on the ATS/ERS criteria.

• Evidence of active myocarditis based on recent cMRI or cFDG-PET.

• Non-smoker.

⁃ Diagnosis STEMI based on 1mm ST elevation in 2 or more contiguous leads.

• Symptom onset within 12 hours.

• Undergoing cardiac intervention for acute coronary syndrome.

• Able to consent for blood draw.

⁃ No known cardiac disease.

• No known cardiovascular risk factors: hypertension, diabetes.

• Non-smoker.

Locations
United States
Iowa
University of Iowa
NOT_YET_RECRUITING
Iowa City
University of Iowa
RECRUITING
Iowa City
Contact Information
Primary
Brenda Werner, RN
brenda-r-werner@uiowa.edu
319-353-8862
Time Frame
Start Date: 2019-05-01
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 120
Treatments
Active_comparator: Sarcoidosis patients without evidence of active myocarditis
A single blood draw.
Experimental: Sarcoidosis patients with evidence of active myocarditis
Two blood draws 2 months apart.
Active_comparator: Acute ST elevation myocardial infarction (STEMI)
Three blood draws, baseline, 6 hours and 24 hours.
Placebo_comparator: Healthy controls
A single blood draw
Sponsors
Leads: Nabeel Hamzeh

This content was sourced from clinicaltrials.gov

Similar Clinical Trials