NCT04696081招募中不适用
Multicenter International Prospective Registry to Identify Major Cardiovascular Events Associated With the Occurrence of Atrial Fibrillation in Active Cancer Patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Occurrence of major cardiovascular events and death of any cause at 1 year
研究概览
简要总结
Atrial fibrillation is a common complication of both cancer and anticancer drugs but the consequences of such events remain poorly known and are not adressed in both phase III oncological trials and cardiological guidelines. The objective of this study is to create a prospective multicenter international registry of adult patients with an active cancer and experiencing atrial fibrillation to study major cardiovascular events occurrence during a 1 year follow-up.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients
- •outpatients or hospitalized patients
- •with a confirmed cancer (other than basal-cell or squamous-cell carcinoma of the skin, primary brain tumor, known intracerebral metastases, or acute leukemia) and an active cancer (defined as cancer that had been diagnosed within the past 6 months or recurrent locally advanced or metastatic cancer, for which anticancer treatment was being given at the time of enrollment or during 6 months before enrollment)
- •at least 1 episode of atrial fibrillation (new onset AF occuring after cancer diagnosis or history of paroxysmal of persistant AF prior to cancer diagnosis and an AF recurrence after cancer diagnosis)
- •in sinus rhythm at the time of cancer diagnosis
排除标准
- •patient with palliative cares or other conditions resulting in short term death (death expected in the month following atrial fibrillation occurrence)
- •history of long-standing persistant or permanent AF prior to cancer diagnosis
结局指标
主要结局
Occurrence of major cardiovascular events and death of any cause at 1 year
时间窗: from inclusion in the registry to 1 year of follow-up
Occurrence of death of any cause, cardiovascular death, heart failure, stroke, myocardial infarction in active cancer patients with atrial fibrillation.
次要结局
- Occurrence of major cardiovascular events and death of any cause at 1 year in prevalent and incident AF patients(from inclusion in the registry to 1 year of follow-up)
- Identifying factors associated with atrial fibrillation recurrence(from inclusion in the registry to 1 year of follow-up)
- Identifying risk factors associated with major and clinically relevant non-major bleedings (2005 ISTH definition)(from inclusion in the registry to 1 year of follow-up)
- Description of the population of active cancer patients experiencing atrial fibrillation (in both prevalent and incidence AF patients).(at the inclusion in the registry)
- Identifying risk factors associated with major cardiovascular events and all cause mortality occurrence(from inclusion in the registry to 1 year of follow-up)
- Description of the management of atrial fibrillation in cancer patients (in both prevalent and incidence AF patients).(from inclusion in the registry to 1 year of follow-up)
- Description of the population of active cancer patients having a major cardiovascular event(from inclusion in the registry to 1 year of follow-up)
- Occurrence of major and clinically relevant non-major bleedings (2005 ISTH definition)(from inclusion in the registry to 1 year of follow-up)
研究者
研究点 (1)
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