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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Siemens Molecular Imaging
Information provided by (Responsible Party):
University of Arkansas
ClinicalTrials.gov Identifier:
NCT01018927
First received: November 16, 2009
Last updated: October 17, 2014
Last verified: October 2014
  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: 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. ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: June 2009
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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: Kedar Jambhekar, MD University of Arkansas for Medical Sciences (UAMS)
  More Information

Additional Information:
No publications provided

Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT01018927     History of Changes
Other Study ID Numbers: 110104
Study First Received: November 16, 2009
Last Updated: October 17, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

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
Blood Protein Disorders
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Immune System Diseases
Immunoproliferative Disorders
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Paraproteinemias
Vascular Diseases

ClinicalTrials.gov processed this record on November 27, 2014