Status:

RECRUITING

Cell Free DNA in Cardiac Sarcoidosis

Lead Sponsor:

Nabeel Hamzeh

Conditions:

Sarcoidosis With Myocarditis

Sarcoidosis

Eligibility:

All Genders

18+ years

Phase:

NA

Brief 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 ventri...

Detailed Description

Sarcoidosis is a multisystem granulomatous disease of unknown cause that can affect any organ in the body, including the heart. Sarcoidosis results from an immune reaction to an environmental exposure...

Eligibility Criteria

Inclusion

  • 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.
  • 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.
  • 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.
  • Healthy controls:
  • Inclusion:
  • No known cardiac disease.
  • No known cardiovascular risk factors: hypertension, diabetes.
  • Non-smoker.

Exclusion

    Key Trial Info

    Start Date :

    May 1 2019

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    June 30 2028

    Estimated Enrollment :

    120 Patients enrolled

    Trial Details

    Trial ID

    NCT03858777

    Start Date

    May 1 2019

    End Date

    June 30 2028

    Last Update

    January 9 2026

    Active Locations (2)

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    Page 1 of 1 (2 locations)

    1

    University of Iowa

    Iowa City, Iowa, United States, 52242

    2

    University of Iowa

    Iowa City, Iowa, United States, 52242