Cardiac Outcomes With Near-Complete Estrogen Deprivation

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Duke University
Study ID
NCT05309655
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 55 Years
Healthy Volunteers
Not accepted

Interventions

  • Adenosine Stress Cardiac Magnetic Resonance Imaging — DRUG
    Adenosine stress CMR test with contrast to include cardiovascular structural and functional measures including myocardial blood flow through quantitative perfusion mapping. Participants will have 3 stress tests as a part of this research. These tests will happen when at the beginning of the study, and then every year for 2 years.
  • Electrocardiogram — DIAGNOSTIC_TEST
    A 12-lead electrocardiogram will be done when at the start of the study and at the participant's 2 year stress test to look at the electrical signals of your heart.
  • Computed Tomography Angiogram — DIAGNOSTIC_TEST
    Contrasted coronary CT angiography will be performed for visual and quantitative analysis of coronary artery plaque burdens.
  • Laboratory Testing — OTHER
    10 teaspoons of blood will be withdrawn at every visit that participants receive a stress test. Participants may have up to six blood draws associated with each imaging visit.
  • Quality of Life Survey — BEHAVIORAL
    A general health status survey with 10 questions and should take about 5-10 minutes to finish. This survey is related to research.

Study Details

The purpose of this research study is to understand what effect near complete estrogen deprivation (NCED) therapy has on the heart in breast cancer patients. Investigators want to understand if NCED changes how the heart works.

Key Dates

Start date
Sep 2, 2022
Status verified
Jan 2026
Primary completion
May 1, 2028
Completion
Dec 1, 2028

Study Design

Enrollment
90 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Near-Complete Estrogen Deprivation Therapy Participants
    Participants will receive cardiac imaging stress tests as well as study laboratory tests to monitor for changes in heart as well 30-day at the end of the study along with annual long-term follow up to 5 years from baseline imaging.

Primary Outcome Measure

Change in Myocardial Blood Flow - 24 months [ Time Frame: At baseline and at 24 months ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Duke Cancer CenterDurhamNorth Carolina27710
Sarah Hatcher, MPH
[email protected]
919-684-0591
Alexandra Thomas, MD (PRINCIPAL_INVESTIGATOR)
Wake Forest Baptist Comprehensive Cancer CenterWinston-SalemNorth Carolina27157
Sarah Hatcher, MPH
[email protected]
919-684-0591
Emily Douglas, MD (PRINCIPAL_INVESTIGATOR)
Virginia Commonwealth University Massey Cancer CenterRichmondVirginia23298
Nicole Kaopua
[email protected]
804-628-7774
Jennifer Jordan, Ph.D (SUB_INVESTIGATOR)

Find similar trials in Durham, NC

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Duke Cancer Center· Durham, NCWake Forest Baptist Comprehensive Cancer Center· Winston-Salem, NCVirginia Commonwealth University Massey Cancer Center· Richmond, VA

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