NCT03553654已完成不适用
Low-dose CT-based Method for Detection of Subclinical Anthracycline-induced Cardiotoxicity
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- cardiomyopathy
研究概览
简要总结
Prospective single arm study to evaluate a low-dose CT-based protocol for early detection of myocardial dysfunction in 50 cancer patients undergoing anthracycline-based chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Ability to understand and the willingness to sign a written informed consent.
- •18-75 year old patients with newly-diagnosed cancer scheduled to undergo anthracycline-based chemotherapy (minimum of 200 mg/m2 of doxorubicin or equivalent) at UCSD Medical Center.
- •Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- •A woman of child-bearing potential is any female (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
- •Has not undergone a hysterectomy or bilateral oophorectomy; or
- •Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)
- •Women of child-bearing potential must have a negative pregnancy test during the screening period.
排除标准
- •Prior chemotherapy with anthracycline;
- •Persistent tachycardia (heart rate>90);
- •LVEF<53% or history of cardiomyopathy or decompensated heart failure;
- •Baseline GLS below lower limit of normal (normal range varies depending on age and gender (23)) or inability to obtain meaningful strain data due to poor quality of Echocardiographic images;
- •Known unrevascularized coronary artery disease, myocardial infarction within 30 days of enrollment;
- •Moderate or severe valvular heart disease;
- •Prior allergy or intolerance to iodinated contrast;
- •Renal failure (GFR<30, creatinine >1.5);
- •Cancer involvement of the heart.
结局指标
主要结局
cardiomyopathy
时间窗: 12 months after completion of chemotherapy
Cardiomyopathy is defined as a decrease in the left ventricular ejection fraction by echocardiography of greater than 10 percentage points, to a value \< 53% (normal reference value for 2D echocardiography).
次要结局
- Change in echocardiographic left ventricular ejection fraction(12 months after completion of chemotherapy)
- Change in left ventricular global longitudinal strain based on echocardiography(12 months after completion of chemotherapy)
- Change in CT-based left ventricular strain parameters(12 months after completion of chemotherapy)
研究者
Anna Narezkina
Assistant Professor
University of California, San Diego
研究点 (2)
Loading locations...
相似试验
进行中（未招募）
不适用
LDCT Screening in Non-smokers in TaiwanLung CancerNCT02611570Academia Sinica, Taiwan12,000
已完成
不适用
Diagnostic intervention study of low-dose CT and multiplex PCR on antibiotic treatment and outcome of community-acquired pneumoniapulmonary infection1001981510024970pneumoniaNL-OMON48670niversitair Medisch Centrum Utrecht3,760
Unknown
不适用
Ultra-Low Dose Computed Tomography For Diagnosis And Follow-Up Of Patients With Diffuse Parenchymal Lung Disease (DPLD)Diffuse Parenchymal Lung DiseaseNCT04392726Sheba Medical Center30
Unknown
不适用
Comparison of Low-radiation Dose CT Angiography With Invasive Coronary Angiography in Stable Coronary DiseaseCoronary Artery DiseaseNCT01476579University Hospital of North Norway769
尚未招募
不适用
Evaluation of ultra low-dose CT for detection of latent tuberculosisNL-OMON54908eids Universitair Medisch Centrum40