Register of Cardiovascular Complications Among People Living With HIV

Обзор

The REgister of cardiovascular COmplications among people living with HIV (RECOVIH) is a single hospital registry of adults living with HIV, with one or more other cardiovascular risk factor, who undergo cardiac examination at the Cardiac Center of the Saint Antoine Hospital. RECOVIH is an observational and prospective, monocentric (institutional) registry, with anonymized cardiac, biochemical and associated data collection.

Подробное описание

This hospital-based cardiac registry maintains data from all non-opposing adults living with HIV, with one or more other cardiac risk factor, who undergo complete cardiac examination at the Cardiac Center at the Saint Antoine Hospital.

RECOVIH registry:

The focus of this hospital-based cardiac registry is on clinical care, particularly on risk stratification, of adults living with HIV.

The register was designed to evaluate echocardiographic, coronarographic, and blood pressure abnormalities among people living with HIV (PLWH).

The primary goal of this single hospital registry is the improvement of patient care, especially risk stratification, by medical audit-type evaluation of cardiac tests and outcomes.

RECOVIH data and research:

Cardiac, biochemical, and associated data collected by this single hospital registry are also used as a source of data for some types of research. This research is particularly timely and relevant as currently little scientific evidence exists describing optimal cardiac care, and risk stratification, for adults living with HIV.

The primary goal of research using RECOVIH data is the quantification of morphologic and functional cardiac abnormalities and blood pressure abnormalities.

The secondary research goal is the identification and description of key aspects of the relationship between HIV, cardiovascular diseases (CVD), and CVD risk factors. Exploration of this complex relationship may help identify and describe the impact of chronic HIV related infection and inflammation, antiretroviral use (ARV), and individual health risks on the development and course of morphologic and functional cardiac abnormalities and blood pressure levels.

Первичные конечные точки

• Cardiovascular mortality [Срок оценки: 20 years]

Вторичные конечные точки (3)

• Echocardiographic profile (composite) [Срок оценки: 20 years]
• Ischemia profile (composite) [Срок оценки: 20 years]
• Blood pressure profile (composite) [Срок оценки: 20 years]

Критерии участия

Критерии включения

• 18 years of age or older
• Known HIV-1 seropositivity for minimum of six months (confirmed by Elisa and Western Blot)
• Underwent complete cardiac examination (echocardiography, ischemia test, ambulatory blood pressure monitoring) between 2005 and 2010 at the Cardiac Center in the Saint Antoine University Hospital in Paris, France
• Presenting a minimum of two cardiovascular risk factors (HIV and a minimum of one other) according to the AFFSSAPS 2005 and Morlat Report 2013.
• Willing and able to give informed consent to participate in the study

Критерии исключения

• Refusal to give or sign informed consent
• Not associated with a social security regime (no health insurance)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Франция · 1 центр

• Division of Cardiology, Saint Antoine University Hospital — Paris

Публикации

• 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. PMID 21750273
• 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. PMID 23149821
• 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. PMID 11797181
• 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. PMID 17258826
• 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. PMID 19397399
• 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. PMID 21217185
• 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. PMID 20739268
• 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 desi PMID 17666313

Идентификаторы

NCT: NCT02453919 · RECOVIH

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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