The Advancing Cardiac Care Unit-based Rapid Assessment and Treatment of hypErcholesterolemia (ACCURATE) Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 4
- 主要终点
- Number of patients with a new diagnosis of FH
研究概览
简要总结
ACCURATE will test the hypothesis that opportunistic genetic testing for Familial Hypercholesterolemia (FH) in patients admitted to hospital with an acute coronary syndrome will increase the diagnosis of FH and will impact patient care and outcomes. The study will recruit patients admitted to hospital with an acute coronary syndrome, and research-based genetic testing will be conducted for known FH-causing genetic variants. The results will be returned to the patients' treating physicians. The primary endpoint will be the number of patients with a new diagnosis of definite FH. The secondary endpoints will be the proportion of patients who undergo intensification of lipid-lowering therapy, the lowest LDL cholesterol level achieved, and the proportion of patients reaching guideline recommended lipid targets in the 15 months after the index acute coronary syndrome.
详细描述
Familial hypercholesterolemia (FH) is an inherited condition characterized by elevated low-density lipoprotein cholesterol (LDL-C) levels and premature atherosclerotic cardiovascular disease (ASCVD). Despite being the most common inherited cardiovascular disorder, it is still highly underdiagnosed and undertreated worldwide. The Advancing Cardiac Care Unit-based Rapid Assessment and Treatment of hypErcholesterolemia (ACCURATE) study was designed to test the hypothesis that opportunistic genetic testing for FH among patients hospitalized for acute coronary syndrome (ACS) will increase the diagnosis of FH and improve patient outcomes. ACCURATE is a non-randomized, controlled trial of patients <60 years old admitted to an acute cardiac unit with ACS and elevated LDL-C levels. The first cohort will consist of a control group of patients presenting with ACS who will be treated according to usual standard-of-care. The second cohort will consist of patients presenting with ACS in whom research-based genetic testing for FH will be performed during hospitalization and the results returned to the treating physicians. The primary endpoint will be the number of patients with a new diagnosis of definite FH. The secondary endpoints will be the proportion of patients who undergo intensification of lipid-lowering therapy, the lowest LDL-C level achieved, and the proportion of patients reaching guideline recommended lipid targets in the 15 months after the index ACS. ACCURATE represents the first clinical trial of genetic testing for FH in the acute cardiac care setting and is expected to help identify optimal approaches to increase the diagnosis and treatment of FH.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age <60 years
- •Admitted to an acute cardiac unit with either:
- •A ST elevation myocardial infarction (STEMI), or
- •A non-ST elevation myocardial infarction (NSTEMI)
- •Maximum lipid level at the time of admission or during the prior 1 year of
- •LDL level ≥4 mmol/L (154 mg/dL) if not on a statin, or
- •LDL-C level ≥2.5 mmol/L (96 mg/dL) if on a statin prior to presentation, or
- •Non-HDL-C ≥4.6 mmol/L (177 mg/dL)
排除标准
- 未提供
研究组 & 干预措施
Observation
Those admitted in the first 6 months of the study that meet the inclusion criteria. Patients will be treated according to the normal standard of care for acute coronary syndrome.
Active-testing
Those admitted between 6-18 months of the study meeting the inclusion criteria. Saliva samples will be collected for DNA testing.
干预措施: Research-based genetic test for Familial Hypercholesterolemia (Diagnostic Test)
结局指标
主要结局
Number of patients with a new diagnosis of FH
时间窗: 1 year
Number of patients with a new diagnosis of definite FH
时间窗: 15 months
次要结局
- Proportion of patients in whom lipid-lowering medication intensified, as defined by an increase the dose of statin, or the addition of a non-statin lipid-lowering medication, in the first year after ACS(1 year)
- Lowest LDL-cholesterol (LDL-C) level achieved in the first year after ACS(1 year)
- Proportion of patients who achieve guideline recommended lipid targets in the first year after ACS(1 year)
- Proportion of patients in whom lipid-lowering medication intensified, as defined by an increase the dose of statin, or the addition of a non-statin lipid-lowering medication, in the 15 months after ACS(15 months)
- Lowest LDL-cholesterol (LDL-C) level achieved in the first 15 months after ACS(15 months)
- Proportion of patients who achieve guideline recommended lipid targets in the first 15 months after ACS(15 months)
研究者
Liam Brunham
Associate Professor
University of British Columbia