Correlation Between Early Myocardial Injury and Intestinal Flora Changes Associated With Oncology Drug Therapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- At least a 10% decrease in the global longitudinal strain
研究概览
简要总结
The purpose of this study was to explore the relationship between early myocardial injury caused by tumor drug therapy and intestinal microbial structure changes by echocardiographic two-dimensional speckle tracking technique and intestinal microflora structure detection.
详细描述
This is a monocentric prospective cohort study in which 50 patients treated for malignant tumors will be included. All participants will be followed for 6 months after the initiation of oncology drug therapy. Echocardiography and 2D speckle tracking will be performed and stool and blood samples will be tested before treatment initiation and at 3 and 6 months after initiation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •With malignant tumors
- •Will receive antitumor drugs
- •Could receive regular follow-up for 6 months
- •Written informed consent
排除标准
- •Satisfactory echocardiographic images could not be obtained
- •Cardiomyopathy
- •Coronary artery disease
- •Heart failure
- •Arrhythmia requiring intervention
- •Moderate or severe valvular disease
- •Acute myocarditis
- •Refractory hypertension
- •Participating in other studies of drug intervention
研究组 & 干预措施
Patients treated with antineoplastic agents
50 patients treated with antineoplastic agents will be enrolled.
干预措施: Antitumor drugs (Drug)
结局指标
主要结局
At least a 10% decrease in the global longitudinal strain
时间窗: 6 months
The primary endpoint is at least a 10% decrease in the global longitudinal strain, determined using cardiac 2D STE and compared with baseline.
次要结局
未报告次要终点