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Clinical Trials/NCT01627600
NCT01627600CompletedNot Applicable

The Atahualpa Project, a 3-phase Epidemiologic Survey

Hospital Clínica Kennedy2 sites in 1 country642 target enrollmentStarted: June 2012Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
642
Locations
2
Primary Endpoint
Evaluation of cardiovascular health status in Atahualpa residents aged 40 years or more

Study Overview

Brief Summary

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.

Study Design

Study Type
Observational
Observational Model
Ecologic Or Community
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
40 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Atahualpa residents aged ≥ 40 years

Exclusion Criteria

  • Patients who do not sign the informed consent form

Outcomes

Primary Outcomes

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Hospital Clínica Kennedy
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Oscar H. Del Brutto, MD

Staff Member, Department of Neurological Sciences

Hospital Clínica Kennedy

Study Sites (2)

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