Register of Cardiovascular Complications Among People Living With HIV

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Register of Cardiovascular Complications Among People Living With HIV

Conditions
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HIV, Cardiovascular Diseases

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria : Refusal to give or sign informed consent Not associated with a social security regime (no health insurance)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| RECOVIH<br>Complete cardiac examination including echocardiography, ischemia tests, and ambulatory blood pressure monitoring. Collection of clinical information and biochemical laboratory results. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular mortality | Cardiovascular mortality as classified using the 10th revision of the International Classification of Diseases (cardiovascular diagnosis codes I 00-I 99). | 20 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Echocardiographic profile (composite) | Parameters concerning - left ventricular dysfunction both systolic and diastolic, valvulopathies, pulmonary pressure, pericardial involvement under cross-sectional echocardiography and tissue Doppler imaging. | 20 years | 
| Ischemia profile (composite) | Parameters of ischemia tests including - exercise tolerance test, and stress-echocardiography under dobutamine or exercise. | 20 years | 
| Blood pressure profile (composite) | Parameters from - ambulatory blood pressure monitoring over 24 hours using a Pressure Holter. | 20 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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functional cardiac abnormality, morphologic cardiac abnormality, blood pressure abnormality