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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2022-05920 | Registry Identifier | CTRP (Clinical Trials Reporting Program) | |
| 21-006790 | Other Identifier | Mayo Clinic Institutional Review Board |
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| Name | Class |
|---|---|
| Florida Heart Research Institute | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 year follow-up | patients who were treated in the year before and are now returning for their 1-year follow-up. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NT-pro-BNP | Diagnostic Test | Blood draw |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Absolute change in AI-ECG probability for LVEF <50% from baseline to 1 year from anthracycline-based therapy |
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Inclusion Criteria:
Exclusion Criteria:
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200 cancer survivors who are 1 year out from anthracycline-based therapy.
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| Name | Affiliation | Role |
|---|---|---|
| Joerg Herrmann, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D004562 | Electrocardiography |
| D004452 | Echocardiography |
| ID | Term |
|---|---|
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Electrocardiogram | Diagnostic Test | electrodes are placed on certain spots and a reading obtained to measure the voltage of the heart |
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| Echocardiogram | Diagnostic Test | medical imaging of the heart |
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Calculation of the change in AI-ECG probability of 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 | 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 |
| 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 |
| 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 |
| D004568 | Electrodiagnosis |
| D057791 | Cardiac Imaging Techniques |
| D003952 | Diagnostic Imaging |
| D014463 | Ultrasonography |