HEART 通路实施
2019年3月1日 更新者：Wake Forest University Health Sciences
HEART 途径：弥合运营、研究和教育之间的差距
本研究的目的是在“真实世界”的临床环境中确定 HEART 通路的有效性，这是一种用于治疗胸痛患者的临床决策辅助工具。
这将通过在研究、教育和卫生系统运营之间建立变革性合作来实现，以更有效和高效地提供患者护理。
研究概览
详细说明
每年有数百万胸痛患者在急诊室 (ED) 就诊。 超过一半的 ED 胸痛患者被送往医院接受进一步检查。 尽管检测率很高，但只有不到十分之一的胸痛患者最终被诊断出患有急性冠脉综合征 (ACS)，估计每年的费用为 130 亿美元。 目前针对急性胸痛的护理模式未能将医疗系统资源（例如住院和心脏检测）集中在最有可能受益的患者身上。
HEART Pathway 结合了临床决策辅助和两次连续肌钙蛋白测量，已开发用于识别胸痛患者，这些患者无需进行客观的心脏测试（压力测试或血管造影）即可安全出院。 之前的回顾性和观察性研究已经证实，使用 HEART 通路可将心脏检测减少 20% 以上，同时保持可接受的低不良事件发生率。 我们现在寻求将 HEART 通路整合到“真实世界”的临床环境中以确定有效性。
该提案的目标是建立一种变革性的合作，弥合研究、教育和卫生系统运营之间的差距，以更有效和高效地提供患者护理。 此次合作的先行者旨在通过将 HEART 通路整合到 Wake Forest Baptist Health (WFBH) 的心血管护理服务中来提高急性胸痛患者的护理质量。 该项目将以我们之前的工作为基础，并提供一个模型，利用美国学术医学中心的教育和运营优势来传播改善护理服务的举措。
研究类型
观察性的
注册 (实际的)
14717
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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North Carolina
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Winston-Salem、North Carolina、美国、27157
- Wake Forest Baptist Medical Center
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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
17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
取样方法
概率样本
研究人群
目标人群是患有急性胸痛，但心电图（ECG）上没有明显的急性冠状动脉综合征（ACS）的成年患者。
因此，将纳入患有急性胸痛的成年患者（>21 岁），提供者为其订购肌钙蛋白，并且心电图上没有 ST 段抬高型心肌梗死 (STEMI) 的证据。
根据维克森林浸信会医疗中心 (WFBMC) 的 STEMI 发生率，我们预计只有不到 5% 的急性胸痛患者会因 ECG 标准而被排除在外。
描述
纳入标准：
- 急诊科 (ED) 就诊时年龄大于或等于 21 岁
- 胸部不适与可能的急性冠状动脉综合征 (ACS) 一致，由主治医师获得心电图 (ECG) 和心脏生物标志物以供患者评估。
排除标准：
- 任何心电图上相邻导联的新 ST 段抬高 (>/= 1 mV)
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
- 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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后 HEART 通路实施
在实施 HEART 通路决策辅助后，将收集有关因胸痛而到急诊科 (ED) 就诊的患者的数据。
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Pre-HEART 通路实施
在实施 HEART 通路决策辅助之前，将收集有关因胸痛就诊于急诊科 (ED) 的患者的数据。
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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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住院率
大体时间：急诊就诊后 30 天
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急诊就诊后 30 天
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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。
调查人员
- 首席研究员：Simon A Mahler, MD, MS、Wake Forest Baptist Medical Center
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
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- Mahler SA, Hiestand BC, Goff DC Jr, Hoekstra JW, Miller CD. Can the HEART score safely reduce stress testing and cardiac imaging in patients at low risk for major adverse cardiac events? Crit Pathw Cardiol. 2011 Sep;10(3):128-33. doi: 10.1097/HPC.0b013e3182315a85.
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- Thygesen K, Alpert JS, Jaffe AS, Simoons ML, Chaitman BR, White HD; Joint ESC/ACCF/AHA/WHF Task Force for the Universal Definition of Myocardial Infarction, Katus HA, Lindahl B, Morrow DA, Clemmensen PM, Johanson P, Hod H, Underwood R, Bax JJ, Bonow RO, Pinto F, Gibbons RJ, Fox KA, Atar D, Newby LK, Galvani M, Hamm CW, Uretsky BF, Steg PG, Wijns W, Bassand JP, Menasche P, Ravkilde J, Ohman EM, Antman EM, Wallentin LC, Armstrong PW, Simoons ML, Januzzi JL, Nieminen MS, Gheorghiade M, Filippatos G, Luepker RV, Fortmann SP, Rosamond WD, Levy D, Wood D, Smith SC, Hu D, Lopez-Sendon JL, Robertson RM, Weaver D, Tendera M, Bove AA, Parkhomenko AN, Vasilieva EJ, Mendis S. Third universal definition of myocardial infarction. Circulation. 2012 Oct 16;126(16):2020-35. doi: 10.1161/CIR.0b013e31826e1058. Epub 2012 Aug 24. No abstract available.
- Wagner EH. Chronic disease management: what will it take to improve care for chronic illness? Eff Clin Pract. 1998 Aug-Sep;1(1):2-4. No abstract available.
- Rosamond W, Flegal K, Friday G, Furie K, Go A, Greenlund K, Haase N, Ho M, Howard V, Kissela B, Kittner S, Lloyd-Jones D, McDermott M, Meigs J, Moy C, Nichol G, O'Donnell CJ, Roger V, Rumsfeld J, Sorlie P, Steinberger J, Thom T, Wasserthiel-Smoller S, Hong Y; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2007 update: a report from the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Circulation. 2007 Feb 6;115(5):e69-171. doi: 10.1161/CIRCULATIONAHA.106.179918. Epub 2006 Dec 28. No abstract available. Erratum In: Circulation. 2007 Feb 6;115(5):e172. Circulation. 2010 Jul 6;122(1):e9. Kissela, Bret [corrected to Kissela, Brett].
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- Fleischmann KE, Goldman L, Johnson PA, Krasuski RA, Bohan JS, Hartley LH, Lee TH. Critical pathways for patients with acute chest pain at low risk. J Thromb Thrombolysis. 2002 Apr;13(2):89-96. doi: 10.1023/a:1016246814235.
- Anderson JL, Adams CD, Antman EM, Bridges CR, Califf RM, Casey DE Jr, Chavey WE 2nd, Fesmire FM, Hochman JS, Levin TN, Lincoff AM, Peterson ED, Theroux P, Wenger NK, Wright RS, Smith SC Jr, Jacobs AK, Adams CD, Anderson JL, Antman EM, Halperin JL, Hunt SA, Krumholz HM, Kushner FG, Lytle BW, Nishimura R, Ornato JP, Page RL, Riegel B; American College of Cardiology; American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 2002 Guidelines for the Management of Patients With Unstable Angina/Non-ST-Elevation Myocardial Infarction); American College of Emergency Physicians; Society for Cardiovascular Angiography and Interventions; Society of Thoracic Surgeons; American Association of Cardiovascular and Pulmonary Rehabilitation; Society for Academic Emergency Medicine. ACC/AHA 2007 guidelines for the management of patients with unstable angina/non-ST-Elevation myocardial infarction: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 2002 Guidelines for the Management of Patients With Unstable Angina/Non-ST-Elevation Myocardial Infarction) developed in collaboration with the American College of Emergency Physicians, the Society for Cardiovascular Angiography and Interventions, and the Society of Thoracic Surgeons endorsed by the American Association of Cardiovascular and Pulmonary Rehabilitation and the Society for Academic Emergency Medicine. J Am Coll Cardiol. 2007 Aug 14;50(7):e1-e157. doi: 10.1016/j.jacc.2007.02.013. No abstract available. Erratum In: J Am Coll Cardiol. 2008 Mar 4;51(9):974.
- Ellestad MH, Savitz S, Bergdall D, Teske J. The false positive stress test. Multivariate analysis of 215 subjects with hemodynamic, angiographic and clinical data. Am J Cardiol. 1977 Nov;40(5):681-5. doi: 10.1016/0002-9149(77)90182-5. No abstract available.
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- Bach DS, Muller DW, Gros BJ, Armstrong WF. False positive dobutamine stress echocardiograms: characterization of clinical, echocardiographic and angiographic findings. J Am Coll Cardiol. 1994 Oct;24(4):928-33. doi: 10.1016/0735-1097(94)90851-6.
- Einstein AJ, Henzlova MJ, Rajagopalan S. Estimating risk of cancer associated with radiation exposure from 64-slice computed tomography coronary angiography. JAMA. 2007 Jul 18;298(3):317-23. doi: 10.1001/jama.298.3.317.
- Thompson RC, Cullom SJ. Issues regarding radiation dosage of cardiac nuclear and radiography procedures. J Nucl Cardiol. 2006 Jan-Feb;13(1):19-23. doi: 10.1016/j.nuclcard.2005.11.004. No abstract available.
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- Backus BE, Six AJ, Kelder JC, Mast TP, van den Akker F, Mast EG, Monnink SH, van Tooren RM, Doevendans PA. Chest pain in the emergency room: a multicenter validation of the HEART Score. Crit Pathw Cardiol. 2010 Sep;9(3):164-9. doi: 10.1097/HPC.0b013e3181ec36d8.
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- Ashburn NP, Snavely AC, Paradee BE, O'Neill JC, Stopyra JP, Mahler SA. Age differences in the safety and effectiveness of the HEART Pathway accelerated diagnostic protocol for acute chest pain. J Am Geriatr Soc. 2022 Aug;70(8):2246-2257. doi: 10.1111/jgs.17777. Epub 2022 Apr 5.
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- Smith LM, Ashburn NP, Snavely AC, Stopyra JP, Lenoir KM, Wells BJ, Hiestand BC, Herrington DM, Miller CD, Mahler SA. Identification of very low-risk acute chest pain patients without troponin testing. Emerg Med J. 2020 Nov;37(11):690-695. doi: 10.1136/emermed-2020-209698. Epub 2020 Aug 4.
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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)
2013年11月1日
初级完成 (实际的)
2019年1月31日
研究完成 (实际的)
2019年1月31日
研究注册日期
首次提交
2014年2月4日
首先提交符合 QC 标准的
2014年2月4日
首次发布 (估计)
2014年2月6日
研究记录更新
最后更新发布 (实际的)
2019年3月4日
上次提交的符合 QC 标准的更新
2019年3月1日
最后验证
2019年3月1日
更多信息
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.