Cancer Survivor Cardiomyopathy Detection

NCT05201014 | Active Not Recruiting

• 3 other identifiers: CASCADENCI-2022-0592021-006790
• Study Type: observational
• Target: 112
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Diseases; Cancer

Outcome Measures

Primary Outcomes (3)

• Diagnostic performance of AI-ECG for left ventricular ejection fraction (LVEF) < 50%

  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%

  1 year post anthracycline therapy

• Diagnostic performance of NT-pro-BNP for left ventricular ejection fraction (LVEF) < 50%

  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%

  1 year post anthracycline therapy

• Diagnostic performance of AI-ECG and NT-pro-BNP for left ventricular ejection fraction (LVEF) < 50%

  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%

  1 year post anthracycline therapy

Secondary Outcomes (5)

• Absolute change in LVEF from baseline to 1 year from anthracycline-based therapy

  1 year

• Absolute change in AI-ECG probability for LVEF <50% from baseline to 1 year from anthracycline-based therapy

  1 year

• Correlation of change in LVEF and AI-ECG probability of LVEF <50% from baseline to 1 year from anthracycline-based therapy

  1 year

• Absolute change in NT-pro-BNP from baseline to 1 year from anthracycline-based therapy

  1 year

• Correlation of change in LVEF and NT-pro-BNP from baseline to 1 year from anthracycline-based therapy

  1 year

Study Arms (2)

1 year follow-up

patients who were treated in the year before and are now returning for their 1-year follow-up.

Diagnostic Test: NT-pro-BNP; Diagnostic Test: Electrocardiogram; Diagnostic Test: Echocardiogram

Prior to anthracycline-based therapy

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.

Diagnostic Test: NT-pro-BNP; Diagnostic Test: Electrocardiogram; Diagnostic Test: Echocardiogram

Interventions

NT-pro-BNP DIAGNOSTIC_TEST

Blood draw

Also known as: Blood Biomarker

1 year follow-up; Prior to anthracycline-based therapy

Electrocardiogram DIAGNOSTIC_TEST

electrodes are placed on certain spots and a reading obtained to measure the voltage of the heart

1 year follow-up; Prior to anthracycline-based therapy

Echocardiogram DIAGNOSTIC_TEST

medical imaging of the heart

1 year follow-up; Prior to anthracycline-based therapy

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

200 cancer survivors who are 1 year out from anthracycline-based therapy.

You may qualify if:

• ≥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.
• Patients with a history of persistent atrial fibrillation (afib) that are not in afib remission. Include if the most recent ECG does not show afib. Atrial flutter treated the same

You may not qualify if:

• LVEF \<50% or prior confirmed history of cardiomyopathy, heart failure, left bundle branch block, or paced rhythm
• Patients with a history of persistent atrial fibrillation (afib) that are not in afib remission. Include if the most recent ECG does not show afib. Atrial flutter treated the same.
• Individuals with pacemakers, defibrillators, or other implanted electronic devices
• Inability/unwillingness of individual to give written informed consent

Sponsors & Collaborators

• Mayo Clinic: lead
• Florida Heart Research Institute: collaborator

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Cardiovascular Diseases; Neoplasms

Interventions

Electrocardiography; Echocardiography

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis; Cardiac Imaging Techniques; Diagnostic Imaging; Ultrasonography

Study Officials

• Joerg Herrmann, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: December 2, 2021
• First Posted: January 21, 2022
• Study Start: March 3, 2022
• Primary Completion (Estimated): September 20, 2026
• Study Completion (Estimated): September 20, 2026
• Last Updated: September 5, 2025

Record last verified: 2025-08

Locations

US (1)