Montefiore Medical Center

Cardiac Sarcoidosis Randomized Trial

Status: Recruiting

Location: Montefiore Medical Center, Ohio State University Medical Center, Tufts Medical Center, University of Michigan, University of Minnesota, University of Utah, Virginia Commonwealth University, Yale-New Haven Hospital

Conditions: Montefiore Medical Center, Ohio State University Medical Center, Tufts Medical Center, University of Michigan, University of Minnesota, University of Utah, Virginia Commonwealth University, Yale-New Haven Hospital

City/State:

New Haven, Connecticut

Boston, Massachusetts

Ann Arbor, Michigan

New York, New York

Columbus, Ohio

Pittsburgh, Pennsylvania

Salt Lake City, Utah

Richmond, Virginia

Contact Information:

David H Birnie, MD
613-696-7269
[email protected]

Janine Ryan, BAH, CCRP
613-696-7000 ext 17077
[email protected]

Brief Summary:

Prospective randomized controlled trial comparing low dose Prednisone(or Prednisolone)/Methotrexate combination to standard dose Prednisone(or Prednisolone) in patients diagnosed with acute active clinically manifest cardiac sarcoidosis and not yet treated.

The Investigators hypothesize that low dose Prednisone(or Prednisolone)/Methotrexate combination will be as effective as standard dose Prednisone(or Prednisolone), and result in significantly better quality of life and less toxicity than standard dose Prednisone(or Prednisolone).

Detailed Description:

Subjects meeting the study inclusion/exclusion criteria will be randomized equally to receive either:

Everywhere but Japan:

  1. Prednisone 0.5 mg kg/day for 6-months (MAX dose 30 mg per day) or
  2. Methotrexate 15-20 mg po, sc, or IM once a week for 6-months + Folic Acid 2 mg OD for 6 months + Prednisone 20 mg day for 1 month, then 10 mg OD for 1 month, then 5 mg OD for one month then STOP
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Brief Summary:
A retrospective, observational study consisting of patients who presents with typical/atypical chest pain and have an ensuing negative ischemic evaluation
Detailed Description:
Multicenter, retrospective, observational study consisting of patients who presents with typical/atypical chest pain to the emergency department and have an ensuing negative ischemic evaluation. Planned to review the subsequent diagnostic process in these patients, including patients with CMRI (Cardiac Magnetic Resonance Imaging), PET (Positron Emission Tomography) imaging for evaluation of myocarditis with the goal of quantifying the number of patients who go on to have a proven diagnosis of myocarditis that can explain their presenting symptoms.
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(281) 713-2962
800 Rockmead Drive, Suite 155
Kingwood, TX 77339
[email protected]

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