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Search / Trial NCT03858777

Cell Free DNA in Cardiac Sarcoidosis

Launched by NABEEL HAMZEH · Feb 26, 2019

Trial Information

Current as of July 22, 2025

Recruiting

Keywords

Sarcoidosis

ClinConnect Summary

This clinical trial is investigating a new way to identify heart inflammation caused by sarcoidosis, a condition where the body’s immune system mistakenly attacks its own tissues. The researchers are focusing on a type of genetic material called cell-free DNA (cfDNA) that is released into the blood from damaged heart cells. By analyzing this cfDNA, the study aims to find a reliable method to detect active heart involvement in sarcoidosis patients, which could help doctors make better treatment decisions and protect heart function.

To participate in this trial, individuals must meet specific criteria. For patients with sarcoidosis, they should have either evidence of active heart inflammation or no heart issues at all. Healthy volunteers without any heart conditions can also join. Participants can expect to provide a blood sample, and their health will be monitored throughout the study. This research is important because it could lead to better ways to diagnose and manage heart problems associated with sarcoidosis, ultimately improving patient care.

Gender

ALL

Eligibility criteria

  • 1. Sarcoidosis patients without evidence of active myocarditis:
  • * Inclusion:
  • 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.
  • * Exclusion:
  • Known cardiac disease.
  • Active smoker.
  • On immunosuppressive therapy.
  • 2. Sarcoidosis patients with evidence of active myocarditis:
  • * Inclusion:
  • Diagnosis of sarcoidosis based on the ATS/ERS criteria.
  • Evidence of active myocarditis based on recent cMRI or cFDG-PET.
  • Non-smoker.
  • * Exclusion:
  • Known cardiac disease other than sarcoidosis.
  • Active smoker.
  • On immunosuppressive therapy.
  • 3. Acute ST elevation myocardial infarction (STEMI):
  • * Inclusion:
  • 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.
  • * Exclusion:
  • Active smoker.
  • Hemodynamically unstable.
  • 4. Healthy controls:
  • * Inclusion:
  • No known cardiac disease.
  • No known cardiovascular risk factors: hypertension, diabetes.
  • Non-smoker.

About Nabeel Hamzeh

Nabeel Hamzeh is a dedicated clinical trial sponsor with a commitment to advancing medical research and improving patient outcomes. With a focus on innovative therapeutic solutions, Mr. Hamzeh leads initiatives that prioritize safety, efficacy, and ethical standards in clinical studies. His expertise spans multiple therapeutic areas, fostering collaboration among research institutions, healthcare professionals, and regulatory bodies. Through meticulous planning and execution, Nabeel Hamzeh aims to contribute significantly to the development of groundbreaking treatments that address unmet medical needs.

Locations

Iowa City, Iowa, United States

Patients applied

0 patients applied

Trial Officials

Nabeel Hamzeh, MD

Principal Investigator

University of Iowa

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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