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Cardiac Fibrosis and Risk Prediction in Cancer Treatment-Related Cardiotoxicity

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ClinicalTrials.gov Identifier: NCT02798679
Recruitment Status : Recruiting
First Posted : June 14, 2016
Last Update Posted : March 25, 2019
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

Brief Summary:
The purpose of this study is to determine whether pre-existing cardiac fibrosis is a predictor of cancer treatment-related cardiotoxicity.

Condition or disease
Cardiotoxicity

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Study Type : Observational
Estimated Enrollment : 158 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cardiac Fibrosis and Risk Prediction in Cancer Treatment-Related Cardiotoxicity
Study Start Date : August 2016
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : March 2021



Primary Outcome Measures :
  1. Cardiotoxicity assessed clinically or by cardiac MRI [ Time Frame: 24 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Consecutive participants with breast cancer or lymphoma scheduled to receive anthracycline-based chemotherapy or trastuzumab.
Criteria

Inclusion Criteria:

  • Stage I-III breast cancer or lymphoma with a >2 year life expectancy
  • A treatment plan that includes anthracyclines and/or trastuzumab
  • Age >45 years
  • Able to hold breath for 10 seconds
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

Exclusion Criteria:

  • Refusal or inability to provide informed consent
  • Known heart failure or LVEF <50%
  • Heart rate over 100 bpm
  • Renal dysfunction with GFR <30 mL/min/1.73m2
  • Participants with pacemakers, defibrillators, functioning neurostimulator devices or other implanted electronic devices
  • Symptomatic claustrophobia
  • Plans to move within 24 months of enrollment

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): NCT02798679


Contacts
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Contact: Gretchen Peichel, RN (612) 626 6237 gpeichel@umn.edu

Locations
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United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Principal Investigator: Chetan Shenoy, MBBS         
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
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Principal Investigator: Chetan Shenoy, MBBS University of Minnesota - Clinical and Translational Science Institute

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Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT02798679     History of Changes
Other Study ID Numbers: 1602M84521
First Posted: June 14, 2016    Key Record Dates
Last Update Posted: March 25, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Cardiotoxicity
Pathologic Processes
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Radiation Injuries
Wounds and Injuries