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

NCT ID: NCT01627600

Last Updated: 2012-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

642 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-06-30

Study Completion Date

2012-10-31

Brief Summary

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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

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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

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Stroke Ischemic Heart Disease

Keywords

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stroke myocardial infarction cardiovascular health population study

Study Design

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Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Atahualpa residents aged ≥ 40 years

Exclusion Criteria

* Patients who do not sign the informed consent form
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universidad de Especialidades Espiritu Santo

OTHER

Sponsor Role collaborator

Hospital Clínica Kennedy

OTHER

Sponsor Role lead

Responsible Party

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Oscar H. Del Brutto, MD

Staff Member, Department of Neurological Sciences

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Oscar H Del Brutto, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Clinica Kennedy

Locations

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Door-to-door survey

Atahualpa, Santa Elena, Ecuador

Site Status

Door-to-Door

Atahualpa, Santa Elena, Ecuador

Site Status

Countries

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Ecuador

References

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Del Brutto OH, Idrovo L, Santibanez R, Diaz-Calderon 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. doi: 10.1159/000080098. Epub 2004 Aug 5.

Reference Type BACKGROUND
PMID: 15297799 (View on PubMed)

Del Brutto OH, Idrovo L, Mosquera A, Navas C, Santibanez R, Cuesta F, Diaz-Calderon E. Stroke in rural Ecuador: a three-phase, door-to-door survey. Neurology. 2004 Nov 23;63(10):1974-5. doi: 10.1212/01.wnl.0000145293.04832.78.

Reference Type BACKGROUND
PMID: 15557530 (View on PubMed)

Del Brutto OH, Mera RM, Rumbea DA, Castillo PR. Periodic limb movements in sleep are associated with hippocampal atrophy in stroke-free community-dwelling older adults. Sleep. 2023 Jun 13;46(6):zsad088. doi: 10.1093/sleep/zsad088. No abstract available.

Reference Type DERIVED
PMID: 36995971 (View on PubMed)

Del Brutto OH, Mera RM, Costa AF, Rumbea DA, Recalde BY, Castillo PR. Long coronavirus disease-related persistent poor sleep quality and progression of enlarged perivascular spaces. A longitudinal study. Sleep. 2022 Sep 8;45(9):zsac168. doi: 10.1093/sleep/zsac168. No abstract available.

Reference Type DERIVED
PMID: 35878737 (View on PubMed)

Del Brutto OH, Mera RM, Costa AF, Recalde BY, Castillo PR. Sleep quality deterioration in middle-aged and older adults living in a rural Ecuadorian village severely struck by the SARS-CoV-2 pandemic. A population-based longitudinal prospective study. Sleep. 2021 Aug 13;44(8):zsab041. doi: 10.1093/sleep/zsab041.

Reference Type DERIVED
PMID: 33608714 (View on PubMed)

Del Brutto OH, Mera RM, Penaherrera E, Costa AF, Penaherrera R, Castillo PR. On the Association Between Sleep Quality and Arterial Stiffness: A Population Study in Community-Dwelling Older Adults Living in Rural Ecuador (The Atahualpa Project). J Clin Sleep Med. 2019 Aug 15;15(8):1101-1106. doi: 10.5664/jcsm.7798.

Reference Type DERIVED
PMID: 31482831 (View on PubMed)

Del Brutto OH, Castillo PR, Sedler MJ, Del Brutto VJ, Zambrano M, Mera RM, Wright CB, Rundek T. Reasons for Declining Consent in a Population-Based Cohort Study Conducted in a Rural South American Community. J Environ Public Health. 2018 Nov 26;2018:8267948. doi: 10.1155/2018/8267948. eCollection 2018.

Reference Type DERIVED
PMID: 30598669 (View on PubMed)

Other Identifiers

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TAP-001-2012

Identifier Type: -

Identifier Source: org_study_id