NCT01627600

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
642

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2012

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

June 15, 2012

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 26, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

October 3, 2012

Status Verified

October 1, 2012

Enrollment Period

4 months

First QC Date

June 15, 2012

Last Update Submit

October 2, 2012

Conditions

Keywords

strokemyocardial infarctioncardiovascular healthpopulation study

Outcome Measures

Primary Outcomes (1)

  • 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)

Study Arms (1)

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.

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

CVH status will be evaluated in all Atahualpa residents aged ≥ 40 years who did not have history of stroke or ischemic heart disease. Certified neurologists and cardiologists will evaluate all individuals who screened as suspected cases of stroke and ischemic heart disease during Phase I of the study, as well as a 2% sample of age- and gender-matched negative individuals. All patients with diagnosis of stroke and ischemic heart disease will be invited to undergo complementary exams to achieve more specific diagnosis.

You may qualify if:

  • Atahualpa residents aged ≥ 40 years

You may not qualify if:

  • Patients who do not sign the informed consent form

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Door-to-door survey

Atahualpa, Santa Elena, 00000, Ecuador

Location

Door-to-Door

Atahualpa, Santa Elena, 0901, Ecuador

Location

Related Publications (7)

  • 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.

    PMID: 15297799BACKGROUND
  • 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.

    PMID: 15557530BACKGROUND
  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

StrokeMyocardial IschemiaMyocardial Infarction

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHeart DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Oscar H Del Brutto, MD

    Hospital Clinica Kennedy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff Member, Department of Neurological Sciences

Study Record Dates

First Submitted

June 15, 2012

First Posted

June 26, 2012

Study Start

June 1, 2012

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

October 3, 2012

Record last verified: 2012-10

Locations