Clinical Trial: Prospective Identification of Cardiac Amyloidosis by Cardiac Magnetic Resonance Imaging

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational

Official Title: The Influence of Amyloid Protein on Myocardial Tissue Characteristics and Function: Prognostic and Diagnostic Significance of Cardiac Magnetic Resonance Findings

Brief Summary: Cardiac amyloidosis describes a process by which abnormally folded proteins infiltrate the heart tissue. Given the insidious nature of this disease process, diagnosis is often too late for a meaningful intervention. Advances in the treatment of the amyloidoses have improved outcomes for patients with these conditions. The focus of this study is to identify the involvement of the heart, most closely associated with mortality, so that aggressive management can be instituted improving prognosis.

Detailed Summary:

RESEARCH PROTOCOL

Hypothesis:

The presence of amyloid protein in the myocardium changes its function and tissue characteristics. These changes are responsible for the poor prognosis of patients with cardiac amyloidosis. Cardiac magnetic resonance imaging (CMR) offers a novel, non-invasive approach to identify cardiac involvement that may impact patient management. This study will include the prospective validation of CMR parameters qualified as being abnormal in the retrospective study (study ID 2012-3315) and the current literature. The myocardium/blood pool inversion time null point ratio (Myo/BlP TI0 ratio), has been qualified as being significantly different when compared to controls in the retrospective study.

Specific Aims:

  1. Validate the diagnostic accuracy of CMR parameters in a prospective manner for cardiac amyloidosis patients.
  2. CMR parameters, including the Myo/BlP TI0 ratio, will be compared to serum biomarkers (TroponinT, NT-proBNP, serum lambda/kappa free light chain concentration), established to have prognostic value in cardiac amyloidosis. Subjects will be followed via death registry and/or medical records to compare the prognostic value of the CMR parameter with the biomarkers.
  3. CMR parameters will be used to assess for the presence of early cardiac involvement in amyloidosis patients without clinically apparent cardiac involvement (as determined by symptoms, biomarkers and/or cardiac imaging).
  4. CMR will be used to follow patients undergoing treatment, when available, to determine whether CMR parameters consistent with the presence of cardiac amyloidosis, change during treatme
    Sponsor: University of Cincinnati

    Current Primary Outcome: Identification of cardiac amyloidosis using contrast cardiovascular MRI [ Time Frame: 2 years ]

    Original Primary Outcome: Same as current

    Current Secondary Outcome: All cause mortality [ Time Frame: two years ]

    Original Secondary Outcome: Same as current

    Information By: University of Cincinnati

    Dates:
    Date Received: June 1, 2015
    Date Started: October 2013
    Date Completion: December 2017
    Last Updated: June 2, 2015
    Last Verified: June 2015