Comparison of Blood Pressure Measurement With an Omron HEM-907 Device in a Clinical Setting and a Research Setting (OMRONHEM-907)
2018年4月10日 更新者：Maxime Lamarre-Cliche、Institut de Recherches Cliniques de Montreal
Automated office blood pressure (AOBP) devices are recommended for high blood pressure diagnosis.
One of those devices is the Omron HEM-907 (Omron Healthcare).
It is currently not known if blood pressure measurements performed with this device in a clinical setting are equivalent to those made in a research setting.
Therefore, this randomized-controlled trial was designed.
It aims to compare the blood pressure measurements performed in a clinical and a research setting.
Seventy patients will be included and randomized to a clinical/research or research/clinical sequence.
研究概览
详细说明
Hypertension is a common condition, with an estimated prevalence around 20 percent in Canada.
It is a major risk factor for cardiovascular disease.
Recently, Hypertension Canada has updated its guidelines and recommend we should consider a 120 mm Hg systolic blood pressure target in high-risk patients aged 50 years or older.
This recommendation derives mainly from the SPRINT trial.
In this trial, blood pressure was measured with an automated oscillometric blood pressure (AOBP) device, the Omron HEM-907 (Omron Healthcare).
However, it is not known if measurements performed with this device in a clinical setting are equivalent to those made in a research setting.
Therefore, this randomized-controlled trial was designed.
It aims to compare the blood pressure measurements of 70 patients in a clinical and a research setting.
Patients will be randomized to a clinical/research or a research/clinical sequence.
研究类型
介入性
注册 (实际的)
70
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
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Quebec
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Montreal、Quebec、加拿大、H2W1R7
- Institut de recherches cliniques de Montreal
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- At least 18 years old
- Hypertensive or presumed hypertensive
- Patients with a scheduled visit at the IRCM hypertension clinic.
Exclusion Criteria:
- Limitation preventing the measurement of blood pressure
- Introduction or withdrawal of any blood pressure-modifying medication starting 4 weeks before the first and until the last study visit.
- Recreative drug use (except cannabis)
- Alcohol use of more than 4 drinks during the day
- New symptoms during the research visit, that warrants a medical evaluation
- Mean systolic blood pressure >180 mm Hg or mean diastolic blood pressure >110 mm Hg (using AOBP)
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：诊断
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Sequence: Clinical/Research
Participants assigned to this arm will have their blood pressure measured in a clinical setting first, and in a research setting second.
The sequence randomization corresponds to the intervention.
Visits will be at least a day apart but within a two-week period.
During the clinical visit, they will have their blood pressure measured with the Omron HEM-907, an automated office blood pressure (AOBP) device.
During the research setting, participants will be guided through a series of research-driven steps such as study questionnaires and completion of consent forms.
They will have their blood pressure measured in both arms with a mercury sphygmomanometer, and then 3 measurements with a mercury sphygmomanometer.
AOBP measurements (Omron HEM-907) will be performed at the end of the visit.
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Participants will be assigned to a sequence of: research visit first/clinical visit second.
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有源比较器：Sequence: Research/Clinical
Participants assigned to this arm will go through the same measurements and procedures exception made of the research-first and clinical-second sequence.
The intervention to which they are randomized corresponds to the sequence of the visits.
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Participants will be assigned to a sequence of: clinical visit first/research visit second.
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Mean automated office blood pressure systolic blood pressure estimates
大体时间：Up to 2 weeks
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Up to 2 weeks
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Mean automated office blood pressure diastolic blood pressure estimates.
大体时间：Up to 2 weeks
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Up to 2 weeks
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Individual unaveraged automated office systolic and diastolic blood pressure measurements (1, 2 and 3)
大体时间：Up to 2 weeks
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Up to 2 weeks
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Ettehad D, Emdin CA, Kiran A, Anderson SG, Callender T, Emberson J, Chalmers J, Rodgers A, Rahimi K. Blood pressure lowering for prevention of cardiovascular disease and death: a systematic review and meta-analysis. Lancet. 2016 Mar 5;387(10022):957-967. doi: 10.1016/S0140-6736(15)01225-8. Epub 2015 Dec 24.
- Pickering TG, James GD, Boddie C, Harshfield GA, Blank S, Laragh JH. How common is white coat hypertension? JAMA. 1988 Jan 8;259(2):225-8.
- Leung AA, Daskalopoulou SS, Dasgupta K, McBrien K, Butalia S, Zarnke KB, Nerenberg K, Harris KC, Nakhla M, Cloutier L, Gelfer M, Lamarre-Cliche M, Milot A, Bolli P, Tremblay G, McLean D, Tran KC, Tobe SW, Ruzicka M, Burns KD, Vallee M, Prasad GVR, Gryn SE, Feldman RD, Selby P, Pipe A, Schiffrin EL, McFarlane PA, Oh P, Hegele RA, Khara M, Wilson TW, Penner SB, Burgess E, Sivapalan P, Herman RJ, Bacon SL, Rabkin SW, Gilbert RE, Campbell TS, Grover S, Honos G, Lindsay P, Hill MD, Coutts SB, Gubitz G, Campbell NRC, Moe GW, Howlett JG, Boulanger JM, Prebtani A, Kline G, Leiter LA, Jones C, Cote AM, Woo V, Kaczorowski J, Trudeau L, Tsuyuki RT, Hiremath S, Drouin D, Lavoie KL, Hamet P, Gregoire JC, Lewanczuk R, Dresser GK, Sharma M, Reid D, Lear SA, Moullec G, Gupta M, Magee LA, Logan AG, Dionne J, Fournier A, Benoit G, Feber J, Poirier L, Padwal RS, Rabi DM; Hypertension Canada. Hypertension Canada's 2017 Guidelines for Diagnosis, Risk Assessment, Prevention, and Treatment of Hypertension in Adults. Can J Cardiol. 2017 May;33(5):557-576. doi: 10.1016/j.cjca.2017.03.005. Epub 2017 Mar 10. Erratum In: Can J Cardiol. 2017 Dec;33(12 ):1733-1734.
- SPRINT Research Group; Wright JT Jr, Williamson JD, Whelton PK, Snyder JK, Sink KM, Rocco MV, Reboussin DM, Rahman M, Oparil S, Lewis CE, Kimmel PL, Johnson KC, Goff DC Jr, Fine LJ, Cutler JA, Cushman WC, Cheung AK, Ambrosius WT. A Randomized Trial of Intensive versus Standard Blood-Pressure Control. N Engl J Med. 2015 Nov 26;373(22):2103-16. doi: 10.1056/NEJMoa1511939. Epub 2015 Nov 9. Erratum In: N Engl J Med. 2017 Dec 21;377(25):2506.
- Padwal RS, Bienek A, McAlister FA, Campbell NR; Outcomes Research Task Force of the Canadian Hypertension Education Program. Epidemiology of Hypertension in Canada: An Update. Can J Cardiol. 2016 May;32(5):687-94. doi: 10.1016/j.cjca.2015.07.734. Epub 2015 Aug 15.
- Kannel WB. Blood pressure as a cardiovascular risk factor: prevention and treatment. JAMA. 1996 May 22-29;275(20):1571-6.
- Myers MG, Valdivieso MA. Use of an automated blood pressure recording device, the BpTRU, to reduce the "white coat effect" in routine practice. Am J Hypertens. 2003 Jun;16(6):494-7. doi: 10.1016/s0895-7061(03)00058-x.
- Edwards C, Hiremath S, Gupta A, McCormick BB, Ruzicka M. BpTRUth: do automated blood pressure monitors outperform mercury? J Am Soc Hypertens. 2013 Nov-Dec;7(6):448-53. doi: 10.1016/j.jash.2013.07.002. Epub 2013 Aug 19.
- Myers MG, Godwin M, Dawes M, Kiss A, Tobe SW, Grant FC, Kaczorowski J. Conventional versus automated measurement of blood pressure in primary care patients with systolic hypertension: randomised parallel design controlled trial. BMJ. 2011 Feb 7;342:d286. doi: 10.1136/bmj.d286.
- Myers MG, Oh PI, Reeves RA, Joyner CD. Prevalence of white coat effect in treated hypertensive patients in the community. Am J Hypertens. 1995 Jun;8(6):591-7. doi: 10.1016/0895-7061(95)00049-U.
- Myers MG, Valdivieso M, Kiss A. Consistent relationship between automated office blood pressure recorded in different settings. Blood Press Monit. 2009 Jun;14(3):108-11. doi: 10.1097/MBP.0b013e32832c5167.
- Agarwal R. Implications of Blood Pressure Measurement Technique for Implementation of Systolic Blood Pressure Intervention Trial (SPRINT). J Am Heart Assoc. 2017 Feb 3;6(2):e004536. doi: 10.1161/JAHA.116.004536.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2017年11月27日
初级完成 (实际的)
2018年3月29日
研究完成 (实际的)
2018年3月29日
研究注册日期
首次提交
2017年11月17日
首先提交符合 QC 标准的
2017年12月1日
首次发布 (实际的)
2017年12月4日
研究记录更新
最后更新发布 (实际的)
2018年4月11日
上次提交的符合 QC 标准的更新
2018年4月10日
最后验证
2018年4月1日
更多信息
与本研究相关的术语
其他研究编号
- OMRON HEM-907
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
according to specific scientifically pertinent demands
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.