NCT01018927

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 16, 2009

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 25, 2009

Completed
7.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2017

Completed
Last Updated

May 31, 2017

Status Verified

May 1, 2017

Enrollment Period

8 years

First QC Date

November 16, 2009

Last Update Submit

May 30, 2017

Conditions

Keywords

Cardiac MR (CMR)Early Myocardial InfiltrationAmyloidLight Chain Deposition DiseaseMultiple Myeloma

Outcome Measures

Primary Outcomes (1)

  • 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.

    The time frame is five additional minutes & three additional images during and MRI.

Study Arms (1)

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

Interventions

Three additional MRI images to determine the role of cardiac MR (CMR) in detecting features of early myocardial infiltration

Additional MRI images

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Multiple Myeloma subjects

You may qualify if:

  • 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

You may not qualify if:

  • Pregnant women
  • Subject with a metallic or electronic or other device that could be affected by the magnet

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University or Arkansas for Medical Sciences (UAMS)

Little Rock, Arkansas, 72205, United States

Location

MeSH Terms

Conditions

Multiple MyelomaAlzheimer Disease

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System DiseasesDementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Tarun Pandey

    University of Arkansas for Medical Sciences (UAMS)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2009

First Posted

November 25, 2009

Study Start

June 1, 2009

Primary Completion

May 30, 2017

Study Completion

May 30, 2017

Last Updated

May 31, 2017

Record last verified: 2017-05

Locations