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Completed

NCT Number: NCT01627600

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

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.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Door-to-Door, Atahualpa, Santa Elena, Ecuador

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Atahualpa residents aged ≥ 40 years

Exclusion criteria

  • Patients who do not sign the informed consent form

Treatment and study plan

Primary outcomes

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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Hospital Clínica Kennedy

Other

Collaborators

  • Universidad de Especialidades Espiritu Santo

Registry information

Official study title

The Atahualpa Project, a 3-phase Epidemiologic Survey

Acronym: TAP

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jun 26, 2012
Registry last updated
Oct 3, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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