CAncer Survivor CArdiomyopathy DEtection Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Mayo Clinic
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Diagnostic performance of AI-ECG for left ventricular ejection fraction (LVEF) < 50%
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥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
排除标准
- •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
研究组 & 干预措施
1 year follow-up
patients who were treated in the year before and are now returning for their 1-year follow-up.
干预措施: NT-pro-BNP (Diagnostic Test)
1 year follow-up
patients who were treated in the year before and are now returning for their 1-year follow-up.
干预措施: Electrocardiogram (Diagnostic Test)
1 year follow-up
patients who were treated in the year before and are now returning for their 1-year follow-up.
干预措施: Echocardiogram (Diagnostic Test)
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.
干预措施: NT-pro-BNP (Diagnostic Test)
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.
干预措施: Electrocardiogram (Diagnostic Test)
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.
干预措施: Echocardiogram (Diagnostic Test)
结局指标
主要结局
Diagnostic performance of AI-ECG for left ventricular ejection fraction (LVEF) < 50%
时间窗: 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%
时间窗: 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%
时间窗: 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%
次要结局
- 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 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)
- 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)
研究者
Joerg Herrmann, MD
Professor of Medicine
Mayo Clinic