Prospective Identification of Cardiac Amyloidosis by Cardiac Magnetic Resonance Imaging

NCT02462213 | Withdrawn DMC

• 1 other identifier: 2013-3043
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Amyloidosis; Paraproteinemias; Cardiomyopathies

Keywords

Cardiac amyloidosis; Cardiac MRI; Infiltrative cardiomyopathies

Outcome Measures

Primary Outcomes (1)

• Identification of cardiac amyloidosis using contrast cardiovascular MRI

  2 years

Secondary Outcomes (1)

• All cause mortality

  two years

Study Arms (2)

Amyloidosis

Patients being managed for amyloidosis without prior history of cardiac involvement

Other: Amyloidosis

Cardiac amyloidosis

Patients being managed for cardiac amyloidosis

Other: Cardiac Amyloidosis

Interventions

Amyloidosis OTHER

Patients with amyloidosis without cardiac involvement will undergo cardiac MRI and possible biochemical analysis during the course of the study.

Amyloidosis

Cardiac Amyloidosis OTHER

Patients with confirmed cardiac amyloidosis will undergo cardiac MRI and possible biochemical analysis during the course of the study.

Cardiac amyloidosis

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with amyloidosis will be recruited from the hematology clinic from participating institutions. Patients with confirmed cardiac amyloidosis will be recruited from either the cardiology or hematology clinics of participating institutions.

You may qualify if:

• Subjects meeting diagnostic criteria for the target population will be recruited for the study. Age range will be 18 to 85 years of age.

Sponsors & Collaborators

• University of Cincinnati: lead
• The Christ Hospital: collaborator

Study Sites (1)

University of Cincinnati

Cincinnati, Ohio, 45227, United States

Location

Related Publications (19)

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  PMID: 22806059 BACKGROUND

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• Dispenzieri A, Lacy MQ, Katzmann JA, Rajkumar SV, Abraham RS, Hayman SR, Kumar SK, Clark R, Kyle RA, Litzow MR, Inwards DJ, Ansell SM, Micallef IM, Porrata LF, Elliott MA, Johnston PB, Greipp PR, Witzig TE, Zeldenrust SR, Russell SJ, Gastineau D, Gertz MA. Absolute values of immunoglobulin free light chains are prognostic in patients with primary systemic amyloidosis undergoing peripheral blood stem cell transplantation. Blood. 2006 Apr 15;107(8):3378-83. doi: 10.1182/blood-2005-07-2922. Epub 2006 Jan 5.

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MeSH Terms

Conditions

Amyloidosis; Paraproteinemias; Cardiomyopathies; Amyloid Neuropathies, Familial

Interventions

Amyloid

Condition Hierarchy (Ancestors)

Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Heart Diseases; Cardiovascular Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Nervous System Diseases; Amyloid Neuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Amyloidosis, Familial; Metabolism, Inborn Errors

Intervention Hierarchy (Ancestors)

Multiprotein Complexes; Macromolecular Substances; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Robert E O'Donnell, MD MSc

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

• Jennifer Daniels, MSc

  University of Cincinnati

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 1, 2015
• First Posted: June 3, 2015
• Study Start: October 1, 2013
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: October 26, 2017

Record last verified: 2017-10

Locations

US (1)