The SMART-ORACLE Study (SMART-ORACLE)
Optimising Risk Assessment With CT-angiography or Calcium Score in Patients at High Risk for a Cardiovascular Event
研究概览
详细说明
Patients with a prior cardiovascular event exhibit an elevated risk for subsequent cardiovascular events. The Second Manifestation of Arterial Disease Study (SMART) has recruited over 10,000 patients since 1996 with clinically manifest cardiovascular disease in a multidisciplinary single center study involving primary care physicians, cardiologists, neurologists, vascular surgeons, vascular medicine specialists and radiologists. Within this study a prediction model was developed to accurately estimate the risk for new cardiovascular events. It is now possible to acquire high-quality motion-free computed tomography (CT) images of the coronary and carotid arteries. Imaging biomarkers extracted from these images may further improve the prediction of future manifestations of arterial disease and personalize disease monitoring and medical care.
The SMART-ORACLE study is a prospective, single center, observational cohort study aiming to include 1500 patients. The primary aim is to identify predictors of future cardiovascular events. Eligible patients will be selected via the recruitment of the original SMART study. Patients participating in the SMART-ORACLE study will undergo calcium scoring in multiple cardiovascular beds and contrast-enhanced CT-scans of the coronary and carotid arteries in addition to the regular SMART investigations. Patients with renal dysfunction will be either excluded from the study or will receive pre-hydration (depending on eGFR) to minimize the risk of contrast nephropathy. Follow-up with questionnaire-based assessment will take place every 26 weeks until death of participant or end of the SMART study, asking participants about possible new cardiovascular events. Endpoints will be adjudicated by a committee of three experts. The aim is to collect 170 future events.
The main analysis will consist of Cox proportional hazard analysis. Imaging biomarkers will be added to the existing prediction model to assess their (independent) discriminatory capacity for future events. The c-statistic will be used to measure the discrimination of each model. Net reclassification improvement tables will be constructed to evaluate the added value of imaging markers in terms of reclassification. Based on a one-year-occurrence rate of subsequent cardiovascular events in the current SMART population database of 2.6%, about 6500 person years of follow-up are needed to obtain the adequate number of endpoints.
研究类型
注册 (预期的)
联系人和位置
学习地点
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Utrecht、荷兰、3508 GA
- UMC Utrecht
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- History of cardiovascular event (coronary carter disease, cardiovascular disease, transient ischemic attack, minor stroke peripheral artery disease , abdominal aortic aneurysm)
- Diabetes Mellitus type 2
- Hypertension (Blood pressure>140/90 mm Hg)
Exclusion Criteria:
- Known renal failure (defined as eGFR <46 ml/min/1.73 m2 estimated based on the modification of diet in renal disease (MDRD) formula)
- Previous allergic reaction to contrast, necessitating medical intervention
- Other contra-indication for CT-scanning (e.g. pregnancy, acute hypotension (<100 mm Hg systolic), clinical instability)
- Prior exposure to ionizing radiation for scientific purposes without advantage for the patient
学习计划
研究是如何设计的？
设计细节
- 观测模型：队列
- 时间观点：预期
队列和干预
团体/队列 |
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SMART
The SMART (Second Manifestation of ARTerial disease) cohort comprises patients at high-risk for or who have clinically manifest cardiovascular disease, including transient ischemic attack, cerebrovascular disease, peripheral artery disease, aneurysma aorta abdominalis, myocardial infarction, coronary ischemia for which coronary intervention is required, renal artery stenosis, diabetes mellitus, hyperlipidemia, hypertension, patients diagnosed with human immunodeficiency virus, pre-eclampsia, HELLP syndrome, abruption placentae and Intrauterine growth restriction in medical history.
Participants are re-invited after 4 years for a second screening.
This screening is performed to study the progression of atherosclerosis and evaluate the effects of the advice of the multidisciplinary team.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Combined endpoint of cardiovascular events
大体时间：Every 26 weeks until death of participant or end of the SMART study, with an expected average of 15 years
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(non-fatal) ischemic stroke (non-fatal) myocardial infarction (cardio)vascular death Endpoints will be adjudicated by a committee of three experts.
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Every 26 weeks until death of participant or end of the SMART study, with an expected average of 15 years
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Carotid artery intervention
大体时间：Every 26 weeks until death of participant or end of the SMART study, with an expected average of 15 years
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Carotid desobstruction or stenting
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Every 26 weeks until death of participant or end of the SMART study, with an expected average of 15 years
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Transient ischemic attack
大体时间：Every 26 weeks until death of participant or end of the SMART study, with an expected average of 15 years
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Every 26 weeks until death of participant or end of the SMART study, with an expected average of 15 years
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Abdominal aorta aneurysm
大体时间：Every 26 weeks until death of participant or end of the SMART study, with an expected average of 15 years
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Non-fatal rupture, stenting or operation of an abdominal aorta aneurysm
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Every 26 weeks until death of participant or end of the SMART study, with an expected average of 15 years
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Peripheral artery disease
大体时间：Every 26 weeks until death of participant or end of the SMART study, with an expected average of 15 years
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Amputation, percutaneous transluminal angioplasty or stenting due to peripheral artery disease
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Every 26 weeks until death of participant or end of the SMART study, with an expected average of 15 years
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Coronary artery intervention
大体时间：Every 26 weeks until death of participant or end of the SMART study, with an expected average of 15 years
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Percutaneous coronary intervention, coronary artery bypass graft
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Every 26 weeks until death of participant or end of the SMART study, with an expected average of 15 years
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All cause mortality
大体时间：Every 26 weeks until death of participant or end of the SMART study, with an expected average of 15 years
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Every 26 weeks until death of participant or end of the SMART study, with an expected average of 15 years
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合作者和调查者
赞助
调查人员
- 首席研究员：Yolanda van der Graaf, Prof. dr.、UMC Utrecht
出版物和有用的链接
一般刊物
- Simons PC, Algra A, van de Laak MF, Grobbee DE, van der Graaf Y. Second manifestations of ARTerial disease (SMART) study: rationale and design. Eur J Epidemiol. 1999 Oct;15(9):773-81. doi: 10.1023/a:1007621514757.
- Dorresteijn JA, Visseren FL, Wassink AM, Gondrie MJ, Steyerberg EW, Ridker PM, Cook NR, van der Graaf Y; SMART Study Group. Development and validation of a prediction rule for recurrent vascular events based on a cohort study of patients with arterial disease: the SMART risk score. Heart. 2013 Jun;99(12):866-72. doi: 10.1136/heartjnl-2013-303640. Epub 2013 Apr 10.
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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