Brief Summary

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Official Title: "The Atahualpa Project, a 3-phase Epidemiologic Survey"

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.

• Study Type: Observational
• Study Design: Observational Model: Ecologic or Community, Time Perspective: Cross-Sectional
• Study Primary Completion Date: October 2012

Detailed Clinical Trial 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.

Arms, Groups and Cohorts in this Clinical Trial

• Atahualpa residents aged ≥ 40 years
  • All Atahualpa residentes aged 40 ≥ years will be screened by field questionnaires. Then, those with suspected stroke or ischemic heart disease will be evaluated by neurologists and cardiologists. Cardiovascular health metrics will be evaluated in those negative for stroke or ischemic heart disease.

Outcome Measures for this Clinical Trial

Primary Measures

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

Criteria for Participation in this Clinical Trial

Inclusion Criteria

• Atahualpa residents aged ≥ 40 years

Exclusion Criteria

• Patients who do not sign the informed consent form

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 40 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial: Accepts Healthy Volunteers

Clinical Trial Investigator Information

• Lead Sponsor
  • Hospital Clínica Kennedy
• Collaborator
  • Universidad de Especialidades Espiritu Santo
• Provider of Information About this Clinical Study
  • Principal Investigator: Oscar H. Del Brutto, MD, Staff Member, Department of Neurological Sciences - Hospital Clínica Kennedy
• Overall Official(s)
  • Oscar H Del Brutto, MD, Principal Investigator, Hospital Clinica Kennedy

References

Del Brutto OH, Idrovo L, Santibáñez R, Díaz-Calderón E, Mosquera A, Cuesta F, Navas C. Door-to-door survey of major neurological diseases in rural Ecuador--the Atahualpa Project: methodological aspects. Neuroepidemiology. 2004 Nov-Dec;23(6):310-6. Epub 2004 Aug 5.

Del Brutto OH, Idrovo L, Mosquera A, Navas C, Santibáñez R, Cuesta F, Díaz-Calderón E. Stroke in rural Ecuador: a three-phase, door-to-door survey. Neurology. 2004 Nov 23;63(10):1974-5.