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Cardiac Fibrosis and Risk Prediction in Cancer Treatment-Related Cardiotoxicity

Sponsor
University of Minnesota (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT02798679
Collaborator
(none)
40
Enrollment
1
Location
73
Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    40 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Cardiac Fibrosis and Risk Prediction in Cancer Treatment-Related Cardiotoxicity
    Study Start Date :
    Aug 1, 2016
    Anticipated Primary Completion Date :
    Sep 1, 2022
    Anticipated Study Completion Date :
    Sep 1, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Cardiotoxicity assessed clinically or by cardiac MRI [24 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    45 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Minnesota Minneapolis Minnesota United States 55455

    Sponsors and Collaborators

    • University of Minnesota

    Investigators

    • Principal Investigator: Chetan Shenoy, MBBS, University of Minnesota

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Minnesota
    ClinicalTrials.gov Identifier:
    NCT02798679
    Other Study ID Numbers:
    • CV-2016-24434
    First Posted:
    Jun 14, 2016
    Last Update Posted:
    May 2, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Cardiotoxicity

    Study Results

    No Results Posted as of May 2, 2022