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RECRUITING
NCT05309655
NA

Cardiac Outcomes With Near-Complete Estrogen Deprivation

Sponsor: Duke University

View on ClinicalTrials.gov

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.

Official title: The Cardiac Outcomes With Near-Complete Estrogen Deprivation (CROWN) Study

Key Details

Gender

FEMALE

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

90

Start Date

2022-09-02

Completion Date

2028-12-01

Last Updated

2026-03-16

Healthy Volunteers

No

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10 teaspoons of blood will be withdrawn at every visit that participants receive a stress test.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

Locations (3)

Duke Cancer Center

Durham, North Carolina, United States

Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, United States

Virginia Commonwealth University Massey Cancer Center

Richmond, Virginia, United States