Cancer Survivor Cardiomyopathy Detection

Recruiting

• Conditions: Cardiovascular Diseases; Cancer
• Interventions: Diagnostic Test: NT-pro-BNP; Diagnostic Test: Electrocardiogram; Diagnostic Test: Echocardiogram

• Registration Number: NCT05201014
• Lead Sponsor: Mayo Clinic

Brief Summary

The purpose of this study is to improve the cardiovascular care of adult cancer survivors. The goal is to obtain the data necessary to plan and develop a nation-wide network of a screening program that can help provide cost-effective and long-term monitoring.

Detailed Description

The primary objective of this study is to define the diagnostic performance and optimal cutoffs of AI-ECG and NT-pro-BNP for the detection of left ventricular dysfunction (LVD, defined as a left ventricular ejection fraction (LVEF) \<50%) in cancer patients at 1 year after completion of anthracycline-based chemotherapy.

Study Timeline

• Study First Submitted: 2021-12-02
• Study First Submitted QC: 2022-01-19
• Study First Posted: 2022-01-21
• Study Start: 2022-03-03
• Status Verified: 2024-06
• Last Update Submitted: 2025-01-05
• Last Update Posted: 2025-01-07
• Primary Completion: 2025-10-31
• Study Completion: 2025-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• ≥18 years of age prior to enrollment and anthracycline start date
• diagnosis of breast cancer, lymphoma, or sarcoma with either planned or at 1 year after completion of anthracycline therapy, including patients from 6-12 months and greater than 1 year post-anthracycline exposure.

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Exclusion Criteria

• LVEF <50% or prior confirmed history of cardiomyopathy, heart failure, persistent atrial fibrillation, left bundle branch block, or paced rhythm
• Individuals with pacemakers, defibrillators, or other implanted electronic devices
• Inability/unwillingness of individual to give written informed consent

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Prior to anthracycline-based therapy	Echocardiogram	patients presenting before the start of anthracycline-based therapy, then to be followed thereafter for 1 year and thereby contributing to the pool of patients with 1-year post-anthracycline assessment.
Prior to anthracycline-based therapy	NT-pro-BNP	patients presenting before the start of anthracycline-based therapy, then to be followed thereafter for 1 year and thereby contributing to the pool of patients with 1-year post-anthracycline assessment.
1 year follow-up	NT-pro-BNP	patients who were treated in the year before and are now returning for their 1-year follow-up.
1 year follow-up	Electrocardiogram	patients who were treated in the year before and are now returning for their 1-year follow-up.
1 year follow-up	Echocardiogram	patients who were treated in the year before and are now returning for their 1-year follow-up.
Prior to anthracycline-based therapy	Electrocardiogram	patients presenting before the start of anthracycline-based therapy, then to be followed thereafter for 1 year and thereby contributing to the pool of patients with 1-year post-anthracycline assessment.

Primary Outcome Measures

Name	Time	Method
Diagnostic performance of AI-ECG for left ventricular ejection fraction (LVEF) < 50%	1 year post anthracycline therapy	Determination of the sensitivity, specificity, positive and negative prediction value as well as area under the curve for receiver operating characteristics for the 12-lead AI ECG algorithm for an LVEF \<50%
Diagnostic performance of NT-pro-BNP for left ventricular ejection fraction (LVEF) < 50%	1 year post anthracycline therapy	Determination of the sensitivity, specificity, positive and negative prediction value as well as area under the curve for receiver operating characteristics for NT-pro-BNP \>125 for an LVEF \<50%
Diagnostic performance of AI-ECG and NT-pro-BNP for left ventricular ejection fraction (LVEF) < 50%	1 year post anthracycline therapy	Determination of the sensitivity, specificity, positive and negative prediction value as well as area under the curve for receiver operating characteristics for the 12-lead AI ECG algorithm and NT-pro-BNP \>125 combined for an LVEF \<50%

Secondary Outcome Measures

Name	Time	Method
Correlation of change in LVEF and AI-ECG probability of LVEF <50% from baseline to 1 year from anthracycline-based therapy	1 year	Calculation of the correlation coefficient of change in LVEF and AI-ECG probability of LVEF \<50% from baseline to 1 year from anthracycline-based therapy
Absolute change in LVEF from baseline to 1 year from anthracycline-based therapy	1 year	Calculation of the the change in LVEF from baseline to 1 year from anthracycline-based therapy
Absolute change in AI-ECG probability for LVEF <50% from baseline to 1 year from anthracycline-based therapy	1 year	Calculation of the change in AI-ECG probability of LVEF \<50% from baseline to 1 year from anthracycline-based therapy
Absolute change in NT-pro-BNP from baseline to 1 year from anthracycline-based therapy	1 year	Calculation of the change NT-pro-BNP from baseline to 1 year from anthracycline-based therapy
Correlation of change in LVEF and NT-pro-BNP from baseline to 1 year from anthracycline-based therapy	1 year	Calculation of the correlation coefficient of change in LVEF and NT-pro-BNP from baseline to 1 year from anthracycline-based therapy

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States