StrokeTAPNCT01627600
Door-to-door Survey of Cardiovascular Health, Stroke and Ischemic Heart Disease in Atahualpa
An observational study of Stroke and Ischemic Heart Disease, run by Hospital Clínica Kennedy at 2 sites in Ecuador.
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. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke, Ischemic Heart Disease
- How many people
- 642 participants
- Where
- 2 sitesEcuador
- Study dates
- Jun 2012to Oct 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Atahualpa residents aged ≥ 40 years
Who cannot join
- Patients who do not sign the informed consent form
Trial locations and contacts
2 sites in 1 country.
Ecuador2 sites
Door-to-door survey
Atahualpa, Santa Elena, 00000
Door-to-Door
Atahualpa, Santa Elena, 0901
About this study
Official title: The Atahualpa Project, a 3-phase Epidemiologic Survey
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.
Read the 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.
- Conditions
- Stroke, Ischemic Heart Disease
- Keywords
- stroke, myocardial infarction, cardiovascular health, population study
- Medical subject headings
- Stroke, Myocardial Ischemia, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: September 2012 (up to 3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2012 (estimated)
- Study startJun 2012
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 642 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Clínica Kennedy
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad de Especialidades Espiritu Santo
- Responsible party
- Principal investigator, Oscar H. Del Brutto, MD, Hospital Clínica Kennedy
- Investigators
- Oscar H Del Brutto, MD, Principal investigator, Hospital Clinica Kennedy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01627600
- Sponsor's protocol ID
- TAP-001-2012
- Acronym
- TAP
- Status last verified
- Oct 2012
- First submitted
- 15 Jun 2012
- Last updated
- 3 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 15297799Del 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.
PubMed 15557530Del 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.
PubMed 36995971Del 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.
PubMed 35878737Del 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.
PubMed 33608714Del 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.
PubMed 31482831Del 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.
PubMed 30598669
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Atahualpa Project, a 3-phase Epidemiologic Survey
- ClinicalTrials.gov ID
- NCT01627600
- Acronym / sponsor ID
- TAP / TAP-001-2012
- Conditions
- Stroke, Ischemic Heart Disease
- Keywords
- stroke, myocardial infarction, cardiovascular health, population study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 642 participants (actual)
- Lead sponsor
- Hospital Clínica KennedyUniversity, hospital or other
- Collaborators
- Universidad de Especialidades Espiritu Santo
- Study start
- Jun 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 26 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Atahualpa residents aged ≥ 40 years
Key exclusion criteria (1 listed)
- Patients who do not sign the informed consent form
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2012.
- Background: PubMed 15297799Del 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.
- Background: PubMed 15557530Del 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.
- Derived from this study: PubMed 36995971Del 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.
- Derived from this study: PubMed 35878737Del 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.
- Derived from this study: PubMed 33608714Del 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.
- Derived from this study: PubMed 31482831Del 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.
- Derived from this study: PubMed 30598669Del 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oscar H Del Brutto, MD principal investigator
Hospital Clinica Kennedy
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Ischemic Heart Disease, run by Hospital Clínica Kennedy at 2 sites in Ecuador.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Ecuador. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of cardiovascular health status in Atahualpa residents aged 40 years or more (time frame: September 2012 (up to 3 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01627600, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2012.