Cancer Survivor Cardiomyopathy Detection

Cancer Clinical Trial

— CASCADE  

Official title:

Cancer Survivor Cardiomyopathy Detection

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05201014
• Other study ID #: 21-006790
• Secondary ID: NCI-2022-05920
• Status: Recruiting
• Start date: March 3, 2022
• Est. completion date: October 31, 2024

Study information

• Verified date: January 2024
• Source: Mayo Clinic
• Contact: Tiffany Hansen
• Phone: 507-293-0196
• Email: Hansen.Tiffany[@]mayo.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: October 31, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• =18 years of age at the time of enrollment

• 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.

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

• Diagnosed with stage 4

• Diagnosed with metastatic disease not being treated with curative intent

• Prior or planned HER2-directed chemotherapy

• Inability/unwillingness of individual to give written informed consent

Related Conditions & MeSH terms

• Cancer
• Cardiomyopathies
• Cardiovascular Diseases

Intervention

Diagnostic Test:
• NT-pro-BNP
Blood draw
• Electrocardiogram
electrodes are placed on certain spots and a reading obtained to measure the voltage of the heart
• Echocardiogram
medical imaging of the heart

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	Miami Heart Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Absolute change in LVEF from baseline to 1 year from anthracycline-based therapy	Calculation of the the change in LVEF from baseline to 1 year from anthracycline-based therapy	1 year
Secondary	Absolute change in AI-ECG probability for LVEF <50% from baseline to 1 year from anthracycline-based therapy	Calculation of the change in AI-ECG probability of LVEF <50% from baseline to 1 year from anthracycline-based therapy	1 year
Secondary	Correlation of change in LVEF and AI-ECG probability of LVEF <50% from baseline to 1 year from anthracycline-based therapy	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	1 year
Secondary	Absolute change in NT-pro-BNP from baseline to 1 year from anthracycline-based therapy	Calculation of the change NT-pro-BNP from baseline to 1 year from anthracycline-based therapy	1 year
Secondary	Correlation of change in LVEF and NT-pro-BNP from baseline to 1 year from anthracycline-based therapy	Calculation of the correlation coefficient of change in LVEF and NT-pro-BNP from baseline to 1 year from anthracycline-based therapy	1 year

External Links

•   Mayo Clinic Clinical Trials