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

Stroke Clinical Trial

— TAP  

Official title:

The Atahualpa Project, a 3-phase Epidemiologic Survey

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01627600
• Other study ID #: TAP-001-2012
• Status: Completed
• Phase: Phase 1
• First received: June 15, 2012
• Last updated: October 2, 2012
• Start date: June 2012
• Est. completion date: October 2012

Study information

• Verified date: October 2012
• Source: Hospital Clínica Kennedy
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ecuador: Ethical Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 642
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• Atahualpa residents aged = 40 years

Exclusion Criteria:

• Patients who do not sign the informed consent form

Study Design

Observational Model: Ecologic or Community, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Coronary Artery Disease
• Heart Diseases
• Ischemic Heart Disease
• Myocardial Ischemia
• Stroke

Locations

Country	Name	City	State
Ecuador	Door-to-Door	Atahualpa	Santa Elena
Ecuador	Door-to-door survey	Atahualpa	Santa Elena

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Clínica Kennedy	Universidad de Especialidades del Espíritu Santo

Country where clinical trial is conducted

Ecuador, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

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