Cancer, Cardiovascular Diseases
Conditions
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.
Interventions
DIAGNOSTIC_TESTNT-pro-BNP
Blood draw
DIAGNOSTIC_TESTElectrocardiogram
electrodes are placed on certain spots and a reading obtained to measure the voltage of the heart
DIAGNOSTIC_TESTEchocardiogram
medical imaging of the heart
Sponsors
Mayo Clinic
Florida Heart Research Institute
Study design
Observational model
CASE_ONLY
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 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 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJoerg Herrmann, MD
Mayo Clinic
Outcome results
None listed