艾滋病毒感染者心血管并发症登记册 (RECOVIH)
HIV 感染者心血管并发症登记册 (RECOVIH) 是针对患有一种或多种其他心血管危险因素、在圣安东尼医院心脏中心接受心脏检查的 HIV 成人感染者的单一医院登记册。
RECOVIH 是一个观察性、前瞻性、单中心(机构)注册中心,具有匿名的心脏、生化和相关数据收集功能。
研究概览
详细说明
这个以医院为基础的心脏登记处保存了所有患有艾滋病毒且具有一种或多种其他心脏危险因素的非反对成年人的数据,他们在圣安东尼医院的心脏中心接受了全面的心脏检查。
RECOVIH 注册表:
这个以医院为基础的心脏登记中心的重点是成人艾滋病毒感染者的临床护理,特别是风险分层。
该登记册旨在评估艾滋病毒感染者 (PLWH) 的超声心动图、冠状动脉造影和血压异常。
这个单一医院注册中心的主要目标是通过对心脏检查和结果进行医疗审核类型评估来改善患者护理,特别是风险分层。
RECOVIH 数据和研究:
该单一医院登记处收集的心脏、生化和相关数据也用作某些类型研究的数据源。 这项研究特别及时和相关,因为目前很少有科学证据来描述成人艾滋病毒感染者的最佳心脏护理和风险分层。
使用 RECOVIH 数据进行研究的主要目标是量化形态学和功能性心脏异常以及血压异常。
第二个研究目标是识别和描述 HIV、心血管疾病 (CVD) 和 CVD 危险因素之间关系的关键方面。 探索这种复杂的关系可能有助于识别和描述慢性 HIV 相关感染和炎症、抗逆转录病毒药物的使用 (ARV) 以及个人健康风险对形态和功能性心脏异常和血压水平的发展和病程的影响。
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名:Franck Boccara, MD, PhD
- 电话号码:+0033 (0) 1 49 28 20 00
- 邮箱:franck.boccara@aphp.fr
研究联系人备份
- 姓名:Mabel Nuernberg, MPH
- 电话号码:+0033 (0) 1 49 28 20 00
学习地点
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Paris、法国、75012
- 招聘中
- Division of Cardiology, Saint Antoine University Hospital
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接触:
- Franck Boccara, MD, PhD
- 电话号码:+0033 (0) 1 49 28 20 00
- 邮箱:franck.boccara@sat.aphp.fr
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接触:
- Mabel Nuernberg, MPH, MA
- 电话号码:+0033 (0) 1 49 28 20 00
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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
取样方法
研究人群
描述
纳入标准:
- 18岁或以上
- 已知 HIV-1 血清阳性至少六个月(经 Elisa 和 Western Blot 确认)
- 2005年至2010年间在法国巴黎圣安东尼大学医院心脏中心接受了完整的心脏检查(超声心动图、缺血测试、动态血压监测)
- 根据 2005 年 AFFSAPS 和 2013 年 Morlat 报告,至少提出两种心血管危险因素(HIV 和至少一种其他因素)。
- 愿意并且能够给予参与研究的知情同意
排除标准 :
- 拒绝给予或签署知情同意书
- 与社会保障制度无关(无健康保险)
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
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恢复性
完整的心脏检查,包括超声心动图、缺血测试和动态血压监测。 收集临床信息和生化实验室结果。 |
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 |
---|---|---|
心血管死亡率
大体时间:20年
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使用国际疾病分类第 10 次修订版对心血管死亡率进行分类(心血管诊断代码 I 00-I 99)。
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20年
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
超声心动图(复合)
大体时间:20年
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有关参数 - 左心室收缩期和舒张期功能障碍、瓣膜病、肺动脉压力、横截面超声心动图和组织多普勒成像下的心包受累。
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20年
|
缺血概况(综合)
大体时间:20年
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缺血测试的参数包括 - 运动耐量测试,以及多巴酚丁胺或运动下的负荷超声心动图。
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20年
|
血压概况(综合)
大体时间:20年
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参数来自 - 使用压力动态心电图进行 24 小时动态血压监测。
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20年
|
合作者和调查者
调查人员
- 学习椅:Ariel Cohen, MD, PhD、Saint Antoine University Hospital
出版物和有用的链接
一般刊物
- Dube MP, Stein JH, Aberg JA, Fichtenbaum CJ, Gerber JG, Tashima KT, Henry WK, Currier JS, Sprecher D, Glesby MJ; Adult AIDS Clinical Trials Group Cardiovascular Subcommittee; HIV Medical Association of the Infectious Disease Society of America. Guidelines for the evaluation and management of dyslipidemia in human immunodeficiency virus (HIV)-infected adults receiving antiretroviral therapy: recommendations of the HIV Medical Association of the Infectious Disease Society of America and the Adult AIDS Clinical Trials Group. Clin Infect Dis. 2003 Sep 1;37(5):613-27. doi: 10.1086/378131. Epub 2003 Aug 15. No abstract available.
- Hsue PY, Hunt PW, Ho JE, Farah HH, Schnell A, Hoh R, Martin JN, Deeks SG, Bolger AF. Impact of HIV infection on diastolic function and left ventricular mass. Circ Heart Fail. 2010 Jan;3(1):132-9. doi: 10.1161/CIRCHEARTFAILURE.109.854943. Epub 2009 Nov 20.
- Palella FJ Jr, Baker RK, Moorman AC, Chmiel JS, Wood KC, Brooks JT, Holmberg SD; HIV Outpatient Study Investigators. Mortality in the highly active antiretroviral therapy era: changing causes of death and disease in the HIV outpatient study. J Acquir Immune Defic Syndr. 2006 Sep;43(1):27-34. doi: 10.1097/01.qai.0000233310.90484.16.
- Fihn SD, Gardin JM, Abrams J, Berra K, Blankenship JC, Dallas AP, Douglas PS, Foody JM, Gerber TC, Hinderliter AL, King SB 3rd, Kligfield PD, Krumholz HM, Kwong RY, Lim MJ, Linderbaum JA, Mack MJ, Munger MA, Prager RL, Sabik JF, Shaw LJ, Sikkema JD, Smith CR Jr, Smith SC Jr, Spertus JA, Williams SV; American College of Cardiology Foundation; American Heart Association Task Force on Practice Guidelines; American College of Physicians; American Association for Thoracic Surgery; Preventive Cardiovascular Nurses Association; Society for Cardiovascular Angiography and Interventions; Society of Thoracic Surgeons. 2012 ACCF/AHA/ACP/AATS/PCNA/SCAI/STS Guideline for the diagnosis and management of patients with stable ischemic heart disease: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines, and the American College of Physicians, American Association for Thoracic Surgery, Preventive Cardiovascular Nurses Association, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons. J Am Coll Cardiol. 2012 Dec 18;60(24):e44-e164. doi: 10.1016/j.jacc.2012.07.013. Epub 2012 Nov 19. No abstract available.
- Mondy KE, Gottdiener J, Overton ET, Henry K, Bush T, Conley L, Hammer J, Carpenter CC, Kojic E, Patel P, Brooks JT; SUN Study Investigators. High Prevalence of Echocardiographic Abnormalities among HIV-infected Persons in the Era of Highly Active Antiretroviral Therapy. Clin Infect Dis. 2011 Feb 1;52(3):378-86. doi: 10.1093/cid/ciq066. Epub 2010 Dec 9.
- Neumann T, Esser S, Potthoff A, Pankuweit S, Neumann A, Breuckmann F, Neuhaus K, Kondratieva J, Buck T, Muller-Tasch T, Wachter R, Prettin C, Gelbrich G, Herzog W, Pieske B, Rauchhaus M, Loffler M, Maisch B, Mugge A, Wasem J, Gerken G, Brockmeyer NH, Erbel R; HIV-HEART Study Investigative Group. Prevalence and natural history of heart failure in outpatient HIV-infected subjects: rationale and design of the HIV-HEART study. Eur J Med Res. 2007 Jun 27;12(6):243-8.
- Wever Pinzon O, Silva Enciso J, Romero J, Makani H, Fefer J, Gandhi V, Bangalore S, Chaudhry FA. Risk stratification and prognosis of human immunodeficiency virus-infected patients with known or suspected coronary artery disease referred for stress echocardiography. Circ Cardiovasc Imaging. 2011 Jul;4(4):363-70. doi: 10.1161/CIRCIMAGING.110.961060. Epub 2011 Jul 12.
- Mariano-Goulart D, Jacquet JM, Molinari N, Bourdon A, Benkiran M, Sainmont M, Cornillet L, Macia JC, Reynes J, Ben Bouallegue F. Should HIV-infected patients be screened for silent myocardial ischaemia using gated myocardial perfusion SPECT? Eur J Nucl Med Mol Imaging. 2013 Jan;40(2):271-9. doi: 10.1007/s00259-012-2262-1. Epub 2012 Nov 14.
- Duong M, Cottin Y, Piroth L, Fargeot A, Lhuiller I, Bobillier M, Grappin M, Buisson M, Zeller M, Chavanet P, Wolf JE, Portier H. Exercise stress testing for detection of silent myocardial ischemia in human immunodeficiency virus-infected patients receiving antiretroviral therapy. Clin Infect Dis. 2002 Feb 15;34(4):523-8. doi: 10.1086/338398. Epub 2002 Jan 2.
- Catzin-Kuhlmann A, Orea-Tejeda A, Castillo-Martinez L, Colin-Ramirez E, Asz D, Aguirre VH, Herrera LE, Valles V, Aguilar-Salinas CA, Sierra J, Calva JJ. Human immunodeficiency virus-infected subjects have no altered myocardial perfusion. Int J Cardiol. 2007 Oct 31;122(1):90-2. doi: 10.1016/j.ijcard.2006.11.040. Epub 2007 Jan 26.
- Mansoor A, Golub ET, Dehovitz J, Anastos K, Kaplan RC, Lazar JM. The association of HIV infection with left ventricular mass/hypertrophy. AIDS Res Hum Retroviruses. 2009 May;25(5):475-81. doi: 10.1089/aid.2008.0170.
- Reinsch N, Neuhaus K, Esser S, Potthoff A, Hower M, Brockmeyer NH, Erbel R, Neumann T; German Competence Network for Heart Failure; German Competence Network for HIV AIDS. Prevalence of cardiac diastolic dysfunction in HIV-infected patients: results of the HIV-HEART study. HIV Clin Trials. 2010 May-Jun;11(3):156-62. doi: 10.1310/hct1103-156.
- Reinsch N, Buhr C, Krings P, Kaelsch H, Kahlert P, Konorza T, Neumann T, Erbel R; Competence Network of Heart Failure. Effect of gender and highly active antiretroviral therapy on HIV-related pulmonary arterial hypertension: results of the HIV-HEART Study. HIV Med. 2008 Aug;9(7):550-6. doi: 10.1111/j.1468-1293.2008.00602.x. Epub 2008 Jun 28.
- Martinez-Garcia T, Sobrino JM, Pujol E, Galvez J, Benitez E, Giron-Gonzalez JA. Ventricular mass and diastolic function in patients infected by the human immunodeficiency virus. Heart. 2000 Dec;84(6):620-4. doi: 10.1136/heart.84.6.620.
- Oliviero U, Bonadies G, Bosso G, Foggia M, Apuzzi V, Cotugno M, Valvano A, Leonardi E, Borgia G, Castello G, Napoli R, Sacca L. Impaired diastolic function in naive untreated human immunodeficiency virus infected patients. World J Cardiol. 2010 Apr 26;2(4):98-103. doi: 10.4330/wjc.v2.i4.98.
- Aberg JA, Gallant JE, Ghanem KG, Emmanuel P, Zingman BS, Horberg MA; Infectious Diseases Society of America. Primary care guidelines for the management of persons infected with HIV: 2013 update by the HIV medicine association of the Infectious Diseases Society of America. Clin Infect Dis. 2014 Jan;58(1):e1-34. doi: 10.1093/cid/cit665. Epub 2013 Nov 13.
- Lundgren JD, Battegay M, Behrens G, De Wit S, Guaraldi G, Katlama C, Martinez E, Nair D, Powderly WG, Reiss P, Sutinen J, Vigano A; EACS Executive Committee. European AIDS Clinical Society (EACS) guidelines on the prevention and management of metabolic diseases in HIV. HIV Med. 2008 Feb;9(2):72-81. doi: 10.1111/j.1468-1293.2007.00534.x.
- Prise en charge médical des personnes vivants avec le VIH. Recommandations du groupe d'experts. Sous la direction du Pr Philippe Morlat et sous l'égide du CNS et de l'ANRS. www.cns.sante.fr. 2013.
- European Association for Cardiovascular Prevention & Rehabilitation; Reiner Z, Catapano AL, De Backer G, Graham I, Taskinen MR, Wiklund O, Agewall S, Alegria E, Chapman MJ, Durrington P, Erdine S, Halcox J, Hobbs R, Kjekshus J, Filardi PP, Riccardi G, Storey RF, Wood D; ESC Committee for Practice Guidelines (CPG) 2008-2010 and 2010-2012 Committees. ESC/EAS Guidelines for the management of dyslipidaemias: the Task Force for the management of dyslipidaemias of the European Society of Cardiology (ESC) and the European Atherosclerosis Society (EAS). Eur Heart J. 2011 Jul;32(14):1769-818. doi: 10.1093/eurheartj/ehr158. Epub 2011 Jun 28.
- Nayak G, Ferguson M, Tribble DR, Porter CK, Rapena R, Marchicelli M, Decker CF. Cardiac diastolic dysfunction is prevalent in HIV-infected patients. AIDS Patient Care STDS. 2009 Apr;23(4):231-8. doi: 10.1089/apc.2008.0142.
- El Hattaoui M, Charei N, Boumzebra D, Aajly L, Fadouach S. [Prevalence of cardiomyopathy in HIV infection: prospective study on 158 HIV patients]. Med Mal Infect. 2008 Jul;38(7):387-91. doi: 10.1016/j.medmal.2008.03.006. Epub 2008 Jun 25. French.
- Karavidas A, Foukarakis M, Lazaros G, Chini M, Fotiadis I, Arapi S, Gialernios T, Potamitis N, Gargalianos P, Matsakas E, Stefanadis C. Assessment of cardiac function with Doppler tissue imaging in asymptomatic HIV-infected patients. Int J STD AIDS. 2008 Apr;19(4):227-31. doi: 10.1258/ijsa.2007.007225.
- Thoni GJ, Schuster I, Walther G, Nottin S, Vinet A, Boccara F, Mauboussin JM, Rouanet I, Ederhy S, Dauzat M, Messner-Pellenc P, Obert P. Silent cardiac dysfunction and exercise intolerance in HIV+ men receiving combined antiretroviral therapies. AIDS. 2008 Nov 30;22(18):2537-40. doi: 10.1097/QAD.0b013e328319806d.
- Lang S, Mary-Krause M, Cotte L, Gilquin J, Partisani M, Simon A, Boccara F, Costagliola D; Clinical Epidemiology Group of the French Hospital Database on HIV. Impact of individual antiretroviral drugs on the risk of myocardial infarction in human immunodeficiency virus-infected patients: a case-control study nested within the French Hospital Database on HIV ANRS cohort CO4. Arch Intern Med. 2010 Jul 26;170(14):1228-38. doi: 10.1001/archinternmed.2010.197.
- Arbab-Zadeh A. Stress testing and non-invasive coronary angiography in patients with suspected coronary artery disease: time for a new paradigm. Heart Int. 2012 Feb 3;7(1):e2. doi: 10.4081/hi.2012.e2. Epub 2012 Feb 8.
- Lewden C, May T, Rosenthal E, Burty C, Bonnet F, Costagliola D, Jougla E, Semaille C, Morlat P, Salmon D, Cacoub P, Chene G, Group AEMS, Mortavic. Changes in causes of death among adults infected by hiv between 2000 and 2005: The
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计的)
研究记录更新
最后更新发布 (实际的)
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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