Observational Registry to Determine the Predictors and Outcomes of Patients at Risk of and Diagnosed With Left Ventricular Thrombus
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,500
- 试验地点
- 8
- 主要终点
- Composite Result
研究概览
简要总结
Left Ventricular Thrombus (LVT) is a blood clot that can develop in a poorly functioning heart. In around 1 in 6 patients who have had a heart attack or diagnosed with heart failure tend to develop blood clots in their main heart chamber.
Having a blot clot in the main heart chamber can lead to serious complications such as stroke. Treatment for blood clots is blood thinning medications, which if taken for a prolonged period of time can result in bleeding which further complicates treatment. We hope to gather information to better understand the factors associated with blood clot formation and management in the lower left chamber of the heart. This understanding will hopefully enable us and others to improve management of this condition in the future and therefore help the wider population. As part of this study, bloods and scan results will be recorded and we will complete a short quality of life questionnaire. When participants come in for routine MRI scan, we may capture additional images for further research analysis.
A sample of blood no more than one tablespoon will be collected for research analysis at the same time as routine blood test. This will occur at baseline and at around 6 months. At 12 months we will repeat the quality of life questionnaire and collect final data.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with LV thrombus or;
- •Patients at risk for developing LV thrombus (e.g severe LV dysfunction, LV aneurysm, MI.
排除标准
- •Age < 18 years
- •Unable to consent
研究组 & 干预措施
LV Thrombus (present)
Patients with a diagnosis of LV thrombus in the setting of LV dysfunction (acute myocardial infarction, Ischaemic Cardiomyopathy (ICM), dilated cardiomyopathy (DCM)).
LV Thrombus (at risk)
Patients that do not have LV thrombus but are at risk for developing thrombus such as those with severe LV dysfunction, LV aneurysms, large territory infarcts will also be included.
结局指标
主要结局
Composite Result
时间窗: From baseline to final 12 month follow up (+/- 2 months)
To measure the composite result of major bleeding (BARC \>3), stroke and systemic embolisation, and all-cause mortality
次要结局
- CMR prediction of thrombus(From baseline to 6 month follow up (+/- 3 months))
- Blood Test(From baseline to 6 month follow up (+/- 3 months))
- Quality of Life Questionnaire(From baseline to final 12 month follow up (+/- 2 months))