Diederichsen Axel Cosmus Pyndt, Rasmussen Lars Melholt, Søgaard Rikke, Lambrechtsen Jess, Steffensen Flemming Hald, Frost Lars, Egstrup Kenneth, Urbonaviciene Grazina, Busk Martin, Olsen Michael Hecht, Mickley Hans, Hallas Jesper, Lindholt Jes Sanddal
Elitary Research Centre of Individualized Medicine in Arterial Disease (CIMA), Department of Cardiology, University Hospital Odense, Odense, Denmark.
Elitary Research Centre of Individualized Medicine in Arterial Disease (CIMA), Department of Clinical Biochemistry and Pharmacology, University Hospital Odense, Odense, Denmark.
Trials. 2015 Dec 5;16:554. doi: 10.1186/s13063-015-1082-6.
The significant increase in the average life expectancy has increased the societal challenge of managing serious age-related diseases, especially cancer and cardiovascular diseases. A routine check by a general practitioner is not sufficient to detect incipient cardiovascular disease.
Population-based randomized clinically controlled screening trial.
45,000 Danish men aged 65-74 years living on the Island of Funen, or in the surrounding communities of Vejle and Silkeborg. No exclusion criteria are used.
One-third will be invited to cardiovascular seven-faceted screening examinations at one of four locations. The screening will include: (1) low-dose non-contrast CT scan to detect coronary artery calcification and aortic/iliac aneurysms, (2) brachial and ankle blood pressure index to detect peripheral arterial disease and hypertension, (3) a telemetric assessment of the heart rhythm, and (4) a measurement of the cholesterol and plasma glucose levels. Up-to-date cardiovascular preventive treatment is recommended in case of positive findings.
To investigate whether advanced cardiovascular screening will prevent death and cardiovascular events, and whether the possible health benefits are cost effective.
Registry-based follow-up on all cause death (primary outcome), and costs after 3, 5 and 10 years (secondary outcome).
Each of the 45,000 individuals is, by EPIDATA, given a random number from 1-100. Those numbered 67+ will be offered screening; the others will act as a control group.
Only those randomized to the screening will be invited to the examination;the remaining participants will not. Numbers randomized: A total of 45,000 men will be randomized 1:2. Recruitment: Enrollment started October 2014.
A 5% reduction in overall mortality (HR=0.95), with the risk for a type 1 error=5% and the risk for a type II error=80%, is expected. We expect a 2-year enrollment, a 10-year follow-up, and a median survival of 15 years among the controls. The attendance to screening is assumed to be 70%.
The primary aim of this so far stand-alone population-based, randomized trial will be to evaluate the health benefits and costeffectiveness of using non-contrast full truncus computer tomography (CT) scans (to measure coronary artery calcification (CAC) and identify aortic/iliac aneurysms) and measurements of the ankle brachial blood pressure index (ABI) as part of a multifocal screening and intervention program for CVD in men aged 65-74. Attendance rate and compliance to initiated preventive actions must be expected to become of major importance.
Current Controlled Trials: ISRCTN12157806 (21 March 2015).
平均预期寿命的显著增加加大了管理严重老年相关疾病（尤其是癌症和心血管疾病）的社会挑战。全科医生的常规检查不足以检测出早期心血管疾病。
基于人群的随机临床对照筛查试验。
居住在菲英岛、或在韦勒和锡尔克堡周边社区的45000名65至74岁的丹麦男性。不设排除标准。
三分之一的人将被邀请到四个地点之一进行心血管七方面筛查检查。筛查将包括：（1）低剂量非增强CT扫描以检测冠状动脉钙化和主动脉/髂动脉瘤；（2）肱动脉和踝臂血压指数以检测外周动脉疾病和高血压；（3）心律的遥测评估；（4）胆固醇和血糖水平的测量。如检查结果呈阳性，建议进行最新的心血管疾病预防性治疗。
研究先进的心血管筛查是否能预防死亡和心血管事件，以及可能的健康益处是否具有成本效益。
基于登记处对全因死亡（主要结果）以及3年、5年和10年后的成本（次要结果）进行随访。
通过EPIDATA为45000名个体中的每一个赋予一个1至100的随机数。编号为67及以上的人将接受筛查；其他人将作为对照组。
只有随机分配到筛查组的人将被邀请参加检查；其余参与者不会被邀请。随机分组数量：总共45000名男性将按1:2随机分组。招募：2014年10月开始招募。
预计总体死亡率降低5%（风险比=0.95），I类错误风险为5%，II类错误风险为80%。预计入组时间为2年，随访时间为10年，对照组的中位生存期为15年。假设筛查的参与率为70%。
到目前为止，这项独立的基于人群的随机试验的主要目的将是评估使用非增强全截断计算机断层扫描（CT）扫描（测量冠状动脉钙化（CAC）并识别主动脉/髂动脉瘤）和测量踝臂血压指数（ABI）作为65至74岁男性心血管疾病多焦点筛查和干预计划一部分的健康益处和成本效益。预计参与率和对启动的预防措施的依从性将变得至关重要。
当前受控试验：ISRCTN12157806（2015年3月21日）。
