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Detection of Chemotherapy Induced Cardiotoxicity

Sponsor
George Washington University (Other)
Overall Status
Completed
CT.gov ID
NCT00636844
Collaborator
(none)
36
Enrollment
1
Location
53
Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To identify patients that are at risk of heart damage after receiving chemotherapy (adriamycin).

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    To identify patients at risk of development of heart damage after receiving chemotherapy by obtaining the genetic profile of those who show: elevation of troponin, left ventricular systolic and diastolic dysfunction, and pro-oxidant stress markers.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    36 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Detection of Chemotherapy Induced Cardiotoxicity
    Study Start Date :
    Jan 1, 2008
    Actual Primary Completion Date :
    Dec 1, 2011
    Actual Study Completion Date :
    Jun 1, 2012

    Arms and Interventions

    Arm Intervention/Treatment
    Group A

    Patients receiving chemotherapy (anthracycline and/or adjuvant trastuzumab) for the first time

    Outcome Measures

    Primary Outcome Measures

    1. The genetic profile of patients with anthracycline-induced elevation of troponin-I [one year]

    Secondary Outcome Measures

    1. Assess the genetic profile of patient with anthracycline-induced left ventricular systolic and diastolic dysfunction [one year]

    2. Assess the relationship of quantitative increases of pro-oxidant stress and a specific genetic profile [one year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • undergoing anthracycline and/or trastuzumab therapy for the first time
    Exclusion Criteria:

    • abnormal ventricular ejection fraction

    • past history of, or active cardiac disease including: MI, CHF, angina, arrhythmia requiring medication, valvular disease, uncontrolled systemic hypertension

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 George Washington University Washington District of Columbia United States 20037

    Sponsors and Collaborators

    • George Washington University

    Investigators

    • Principal Investigator: Jannet Lewis, MD, George Washington University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    George Washington University
    ClinicalTrials.gov Identifier:
    NCT00636844
    Other Study ID Numbers:
    • JL-001
    First Posted:
    Mar 17, 2008
    Last Update Posted:
    Mar 13, 2013
    Last Verified:
    Aug 1, 2012
    Keywords provided by George Washington University
    chemotherapy, cardiotoxicity
    Additional relevant MeSH terms:
    Cardiotoxicity

    Study Results

    No Results Posted as of Mar 13, 2013