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Active, Not Recruiting

NCT Number: NCT05201014

Cancer Survivor Cardiomyopathy Detection

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Cardiovascular Diseases Cancer Neoplasms

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.
  • 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

Exclusion criteria

  • 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

Treatment and study plan

NT-pro-BNP

Diagnostic Test

Blood draw

Other names: Blood Biomarker

Electrocardiogram

Diagnostic Test

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

Echocardiogram

Diagnostic Test

medical imaging of the heart

Primary outcomes

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

    Time frame: 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%

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

    Time frame: 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%

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

    Time frame: 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 outcomes

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

    Time frame: 1 year

    Calculation of the the change in LVEF from baseline to 1 year from anthracycline-based therapy

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

    Time frame: 1 year

    Calculation of the change in AI-ECG probability of LVEF <50% from baseline to 1 year from anthracycline-based therapy

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

    Time frame: 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

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

    Time frame: 1 year

    Calculation of the change NT-pro-BNP from baseline to 1 year from anthracycline-based therapy

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

    Time frame: 1 year

    Calculation of the correlation coefficient of change in LVEF and NT-pro-BNP from baseline to 1 year from anthracycline-based therapy

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • Florida Heart Research Institute

Registry information

Official study title

CAncer Survivor CArdiomyopathy DEtection Pilot Study

Acronym: CASCADE

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Jan 21, 2022
Registry last updated
Sep 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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