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临床试验/NCT02264509
NCT02264509已完成不适用

Prevalence and Risk Factors of Arterial Insufficiency in Patients With HIV / AIDS

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran1 个研究点 分布在 1 个国家目标入组 206 人开始时间: 2014年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
206
试验地点
1
主要终点
Arterial insufficiency

研究概览

简要总结

The purpose of this study is to determine the risk factors associated with the occurrence of arterial insufficiency in patients with HIV / AIDS, and to identify the prevalence of this disease. The estimated prevalence is 10%, similar to that reported in the general population.

详细描述

A case study nested in a cohort of patients with HIV / AIDS at Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico, with a cohort of 1500 patients , a sample size of 206 individuals was calculated. Data collection was performed in a prospective cross shape.

During the interview, written informed consent for inclusion in the study, along with a standard query of vascular surgery in which the patient's history as well as cardiovascular risk factors. Also, a vascular physical examination including palpation of pulses in upper and lower extremities (brachial, radial, ulnar, femoral, popliteal, posterior tibial and dorsalis pedis), femoral murmurs search and determining ankle / brachial indexes with a standardized method.

In determining the ABI was counted with a Doppler ultrasound 8 mHz, transducer gel and a sleeve for manual measurement of blood pressure, 20% longer than the largest diameter of the arm circumference.

If the patient is diagnosed with, symptomatic or asymptomatic arterial insufficiency, ABI measurements were performed at rest and effort, plus pressure index finger-arm or plethysmography. Patients with altered rates were followed in vascular surgery care.

The data were recorded in a single database unique protected by password. The results were analyzed using the statistical program STATA v 9.0.

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 89 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with HIV / AIDS are included in active consultation of Infectious Diseases INCMNSZ and sign informed consent.

排除标准

  • Patients who do not wish to participate in the study and those who did not complete their interview and vascular physical examination.

结局指标

主要结局

Arterial insufficiency

时间窗: 1 time

Arterial insufficiency is measured by Ankle / brachial index described as ABI\<0.9 or ABI \>1.2

次要结局

  • Smoking(1 time)
  • Age(1 time)
  • Gender(1 time)
  • Diabetes mellitus(1 time)
  • Hypercholesterolemia(1 time)
  • Hypertriglyceridemia(1 time)
  • Hypoalphalipoproteinemia(1 time)
  • Stroke(1 time)
  • Drug abuse(1 time)
  • Viral Load(1 time)
  • CD4(1 time)
  • HAART (Highly active anti-retroviral therapy)(1 time)
  • Smoking index(1 time)
  • Hypertension (High blood pressure)(1 time)
  • Ischemic heart disease(1 time)
  • AIDS(1 time)
  • Diagnostic Time of HIV(1 time)
  • Time HAART(1 TIME)

研究者

发起方
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
申办方类型
Other
责任方
Principal Investigator
主要研究者

Carlos Hinojosa

subdirector of clinical research

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

研究点 (1)

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