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临床试验/NCT01627600
NCT01627600已完成不适用

The Atahualpa Project, a 3-phase Epidemiologic Survey

Hospital Clínica Kennedy2 个研究点 分布在 1 个国家目标入组 642 人开始时间: 2012年6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
642
试验地点
2
主要终点
Evaluation of cardiovascular health status in Atahualpa residents aged 40 years or more

研究概览

简要总结

The aim of the Atahualpa project is to evaluate the cardiovascular (CVH) status of the inhabitants of a rural village of coastal Ecuador as well as to determine the prevalence and retrospective incidence of stroke and ischemic heart disease. The protocol may be used as a pilot for large-scale studies attempting to evaluate the CVH of rural or even urban centers of Latin America, to implement cost-effective strategies directed to reduce the burden of stroke and cardiovascular diseases in the population at large.

详细描述

This is a 3-phase epidemiological study. During Phase I, two general physicians and a nurse will perform a door-to-door survey of all Atahualpa residents aged ≥ 40 years. These persons will be eligible for being screened with standardized questionnaires to identify those with suspected stroke or ischemic heart disease, and to evaluate their cardiovascular health (CVH). Persons will be directly interviewed unless aphasic or mentally impaired; in such cases, relatives or caregivers will answer the questions. We plan to use the epidemiologic method of capture-recapture to enhance the detection of all possible cases of stroke and ischemic heart disease [13]. So, besides the door-to-door survey, we will review the medical records from the only one health center of Atahualpa, as well as the original files of our survey performed in 2003 at the same village [12].

In Phase II, certified neurologists and cardiologists will move to Atahualpa to examine all individuals who screened as suspected cases of stroke or ischemic heart disease. In addition, a random sample of 2% of individuals who were considered negative during the screening phase (matched by age and gender to suspected cases) will also undergo a complete neurologic and cardiologic examination to assess possible false negative cases during the survey. In Phase III, all patients with a clinical diagnosis of stroke and ischemic heart disease will be invited to undergo further examination in Guayaquil.

研究设计

研究类型
Observational
观察模型
Ecologic Or Community
时间视角
Cross Sectional

入排标准

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

入选标准

  • Atahualpa residents aged ≥ 40 years

排除标准

  • Patients who do not sign the informed consent form

结局指标

主要结局

Evaluation of cardiovascular health status in Atahualpa residents aged 40 years or more

时间窗: September 2012 (up to 3 months)

population will be screened with field questionnaries (3 months), then cardiologists and neurologists will review suspected cases (1 week), then, consented patients will undergo complementary exams

次要结局

未报告次要终点

研究者

发起方
Hospital Clínica Kennedy
申办方类型
Other
责任方
Principal Investigator
主要研究者

Oscar H. Del Brutto, MD

Staff Member, Department of Neurological Sciences

Hospital Clínica Kennedy

研究点 (2)

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