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Cardiac Outcomes With Near-Complete Estrogen Deprivation

NCT05309655 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2026-03-16

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Adenosine Stress Cardiac Magnetic Resonance Imaging

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.

DIAGNOSTIC_TEST

Electrocardiogram

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.

DIAGNOSTIC_TEST

Computed Tomography Angiogram

Contrasted coronary CT angiography will be performed for visual and quantitative analysis of coronary artery plaque burdens.

OTHER

Laboratory Testing

10 teaspoons of blood will be withdrawn at every visit that participants receive a stress test.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.

BEHAVIORAL

Quality of Life Survey

A general health status survey with 10 questions and should take about 5-10 minutes to finish. This survey is related to research.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Duke University

    lead OTHER

Principal Investigators

  • Alexandra Thomas, MD · Duke University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-02
Primary Completion
2028-05-01
Completion
2028-12-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05309655 on ClinicalTrials.gov