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Detecting Early Myocardial Infiltration w/Amyloid & Light Chain Deposition Disease in Multiple Myeloma Subjects

This study has been terminated.
(PI does not have time to continue study)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01018927
First Posted: November 25, 2009
Last Update Posted: May 31, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Siemens Molecular Imaging
Information provided by (Responsible Party):
University of Arkansas
  Purpose
The purpose of this study is to see if MRI techniques can be used for early evaluation of cardiac amyloidosis which is sometimes seen in individuals with multiple myeloma. Cardiac amyloidosis is a medical disorder that decreases heart function.

Condition Intervention
Multiple Myeloma Device: Administering three additional MRI images

Study Type: Observational
Study Design: Observational Model: Other
Time Perspective: Prospective
Official Title: Role of Cardiac MR (CMR) In Detecting Features of Early Myocardial Infiltration With Amyloid and Light Chain Deposition Disease in Subjects With Multiple Myeloma

Resource links provided by NLM:


Further study details as provided by University of Arkansas:

Primary Outcome Measures:
  • This study is to see if MRI techniques can be used for early evaluation of cardiac amyloidosis which is sometimes seen in individuals with multiple myeloma. [ Time Frame: The time frame is five additional minutes & three additional images during and MRI. ]

Enrollment: 44
Study Start Date: June 2009
Study Completion Date: May 30, 2017
Primary Completion Date: May 30, 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Additional MRI images
Prospective review of 100 CMR studies performed on multiple myeloma patients referred for cardiac evaluation by MRI. Three additional MRI images will be performed to determine the role of cardiac MR (CMR) in detecting features of early myocardial infiltration
Device: Administering three additional MRI images
Three additional MRI images to determine the role of cardiac MR (CMR) in detecting features of early myocardial infiltration

Detailed Description:
The purpose is to investigate the use of multiple newer CMR techniques for early evaluation of cardiac amyloidosis in multiple myeloma.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Multiple Myeloma subjects
Criteria

Inclusion Criteria:

  • All races and ethnic groups
  • Male and female ages 18-80 years of age
  • History of multiple myeloma
  • CMR study for evaluation for cardiac amyloidosis

Exclusion Criteria:

  • Pregnant women
  • Subject with a metallic or electronic or other device that could be affected by the magnet
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01018927


Locations
United States, Arkansas
University or Arkansas for Medical Sciences (UAMS)
Little Rock, Arkansas, United States, 72205
Sponsors and Collaborators
University of Arkansas
Siemens Molecular Imaging
Investigators
Principal Investigator: Tarun Pandey University of Arkansas for Medical Sciences (UAMS)
  More Information

Additional Information:
Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT01018927     History of Changes
Other Study ID Numbers: 110104
First Submitted: November 16, 2009
First Posted: November 25, 2009
Last Update Posted: May 31, 2017
Last Verified: May 2017

Keywords provided by University of Arkansas:
Cardiac MR (CMR)
Early Myocardial Infiltration
Amyloid
Light Chain Deposition Disease
Multiple Myeloma

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases