A Study of Autoimmune Functions in Patients with Myocarditis

Overview

About this study

The purpose of this research is to study immune cells called T cells and monocytes (types of blood cells that fight infection and can also cause autoimmune disease) that may damage heart tissue during myocarditis (inflammation of the heart muscle). Cytokines (proteins that send signals between cells) found in the blood will be studied for their effects on blood immune cells to better understand how they can lead to heart failure during and after myocarditis.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

Inclusion Criteria:

  • Symptom onset less than 6 months prior to enrollment.
  • An acute clinical syndrome compatible with myocarditis consisting of either heart failure or chest pain typical of an acute myocardial infarction.
  • Discrete regional wall motion abnormalities on echocardiogram or CRM with an ejection fraction 50%.
  • A globally dilated left ventricle for DCM patients.
  • A coronary angiogram or coronary CT scan with no greater than 50% stenosis in any epicardial coronary artery or a CRM with no regions of post-gadolinium endomyocardial hyper enhancement to exclude ischemic cardiomyopathy.
  • For myocarditis patients- either an endomyocardial biopsy that meets the “Dallas Criteria” for myocarditis or borderline myocarditis or a CRM scan that meets Lake Louise diagnostic criteria for acute myocarditis.
  • Echocardiography may be substituted for CRM when CRM is contraindicated for patients for reasons such as the presence of a pacemaker or claustrophobia.
  • Ability to sign informed consent.

Exclusion Criteria:

  • Diagnosis of ischemic, valvular, or congenital cardiomyopathy by echocardiogram or CRM.
  • Serum creatinine greater than 2.0 mg/dL or an estimated GFR of <30cc/min.
  • Coronary artery disease (one or more lesions >50%).
  • Methamphetamine use in the last 5 years.
  • History of alcohol use exceeding 3 drinks per day.
  • Cardiac transplant recipient.
  • Myocardial biopsy demonstrates evidence of hemochromatosis or amyloidosis.
  • Other potential etiology of cardiomyopathy such as a history of receiving chemotherapy, uncorrected thyroid disease, uncontrolled hypertension despite medical therapy, hypertrophic cardiomyopathy, significant primary valvular disease.
  • Evidence of ongoing bacteremia.
  • History of malignancy treated with chemotherapy or chest radiation within the last five years or life threatening disease that would likely decrease life expectancy to less than three years.
  • Pregnancy.
  • Lack of ability or refusal to sign informed consent.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Leslie Cooper, M.D.

Open for enrollment

Contact information:

Katrina Taylor

(904)953-9708

Taylor.Katrina@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

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