Door-to-door Survey of Cardiovascular Health, Stroke and Ischemic Heart Disease in Atahualpa "TAP"

Completed

Phase 1 Results N/A

Trial Description

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.

Detailed Description

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.

Conditions

Trial Design

  • Observation: Ecologic or Community
  • Perspective: Cross-Sectional
  • Sampling: Probability Sample

Trial Population

CVH status will be evaluated in all Atahualpa residents aged ≥ 40 years who did not have history of stroke or ischemic heart disease. Certified neurologists and cardiologists will evaluate all individuals who screened as suspected cases of stroke and ischemic heart disease during Phase I of the study, as well as a 2% sample of age- and gender-matched negative individuals. All patients with diagnosis of stroke and ischemic heart disease will be invited to undergo complementary exams to achieve more specific diagnosis.

Outcomes

Type Measure Time Frame Safety Issue
Primary Evaluation of cardiovascular health status in Atahualpa residents aged 40 years or more September 2012 (up to 3 months) No

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