- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01627600
Door-to-door Survey of Cardiovascular Health, Stroke and Ischemic Heart Disease in Atahualpa (TAP)
The Atahualpa Project, a 3-phase Epidemiologic Survey
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Santa Elena
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Atahualpa, Santa Elena, Ecuador, 00000
- Door-to-door survey
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Atahualpa, Santa Elena, Ecuador, 0901
- Door-to-Door
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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.
Description
Inclusion Criteria:
- Atahualpa residents aged ≥ 40 years
Exclusion Criteria:
- Patients who do not sign the informed consent form
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Evaluation of cardiovascular health status in Atahualpa residents aged 40 years or more
Time Frame: September 2012 (up to 3 months)
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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
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September 2012 (up to 3 months)
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Oscar H Del Brutto, MD, Hospital Clínica Kennedy
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TAP-001-2012
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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