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临床试验/NCT04330287
NCT04330287招募中不适用

A Prospective, Epidemiologic and Multicentre Trial to Determine the Cardiovascular Risk, New Cardiovascular Events and the Cardiovascular Diseases in HIV-infected Patients: 15 Year Follow up

University Hospital, Essen5 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2020年5月11日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
2,000
试验地点
5
主要终点
Detection of frequency, severity of cardiovascular diseases - especially of coronary artery disease - in patients with HIV-Infection

研究概览

简要总结

The HIV/HEART Aging study (HIVH) is an ongoing, prospective, multicentre trial that was conducted to assess the incidence, the prevalence and the clinical course of cardiovascular diseases (CVD) in HIV-infected patients. The study population includes outpatients from specialized HIV-care units of the German Ruhr region, who were at least 18 years of age, were known to have a HIV-infection and exhibited a stable disease status within 4 weeks before inclusion into the trial. From March 2004 (Pilot phase) to October 2022 (15 year Follow-up) 1858 HIV+ patients were recruited in a consecutive manner. The standardised examinations included a targeted assessment of medical history and physical examination. Blood was drawn for comprehensive laboratory tests including HIV specific parameters (CD4 cell count, HIV-1 RNA levels) and cardiovascular items (lipid concentrations, BNP values and renal parameters). Furthermore, non-invasive tests were performed during the initial visit, including additional heart rate and blood pressure measurements, electrocardiogram (ECGs) and transthoracic echocardiography (TTE). Examinations were completed in accordance with previously defined standard operating procedures. CVD were defined as coronary, cerebrovascular, peripheral arterial disease, heart failure or cardiac vitium.

详细描述

A comprehensive detailed description of the study procedures had been previously published (European Journal of medical research 2007;12:243-248).

Comprehensive non invasive cardiovascular examination

  • Anamnesis
  • File recherche,Physical examination
  • Documentation of the cardiovascular and antiretroviral medical therapy
  • Electrocardiogram
  • Transthoracic echocardiography (optional)
  • Exercise electrocardiogram (optional)
  • Exercise Montreal Cognitive Assessment test (optional)
  • Exercise the Grooved Pegboard test (optional)
  • Blood and stool sample collection (optional)
  • Questionnaire to quality of life and health economics

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age > 18 years
  • Known HIV-infection
  • Signed informed consent

排除标准

  • Acute cardiovascular disease
  • Unstable hemodynamic status in the three weeks before inclusion
  • Pregnancy

结局指标

主要结局

Detection of frequency, severity of cardiovascular diseases - especially of coronary artery disease - in patients with HIV-Infection

时间窗: Baseline up to 15 year follow up

Calculation of the Framingham Risk Score. It was assumed, that in the next 10 years the individual cardiovascular risk varies between maximal 20% and minimal 0%.

Detection of progression of cardiovascular diseases - especially of coronary artery disease - in patients with HIV-Infection

时间窗: Baseline up to 15 year follow up

Calculation of Odds Ratio

次要结局

  • Impact on cardiovascular risk on amount of atherosclerosis(Baseline up to 15 year follow up)
  • Impact on life quality(Baseline up to 15 year follow up)
  • Impact on cardiovascular risk, amount of atherosclerosis and life quality(Baseline up to 15 year follow up)

研究者

发起方
University Hospital, Essen
申办方类型
Other
责任方
Principal Investigator
主要研究者

Stefan Esser M.D.

Prof. M.D. Head of HPSTD Ambulance, University Hospital, Essen, Principal Investigator

University Hospital, Essen

研究点 (5)

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