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

This study has been completed.
Sponsor:
Collaborator:
Universidad de Especialidades Espiritu Santo
Information provided by (Responsible Party):
Oscar H. Del Brutto, MD, Hospital Clínica Kennedy
ClinicalTrials.gov Identifier:
NCT01627600
First received: June 15, 2012
Last updated: October 2, 2012
Last verified: October 2012
  Purpose

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.


Condition Phase
Stroke
Ischemic Heart Disease
Phase 1

Study Type: Observational
Study Design: Observational Model: Ecologic or Community
Time Perspective: Cross-Sectional
Official Title: The Atahualpa Project, a 3-phase Epidemiologic Survey

Resource links provided by NLM:


Further study details as provided by Hospital Clínica Kennedy:

Primary Outcome Measures:
  • Evaluation of cardiovascular health status in Atahualpa residents aged 40 years or more [ Time Frame: September 2012 (up to 3 months) ] [ Designated as safety issue: No ]
    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


Enrollment: 642
Study Start Date: June 2012
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability 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.

Criteria

Inclusion Criteria:

  • Atahualpa residents aged ≥ 40 years

Exclusion Criteria:

  • Patients who do not sign the informed consent form
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01627600

Locations
Ecuador
Door-to-door survey
Atahualpa, Santa Elena, Ecuador, 00000
Door-to-Door
Atahualpa, Santa Elena, Ecuador, 0901
Sponsors and Collaborators
Hospital Clínica Kennedy
Universidad de Especialidades Espiritu Santo
Investigators
Principal Investigator: Oscar H Del Brutto, MD Hospital Clinica Kennedy
  More Information

Publications:
Responsible Party: Oscar H. Del Brutto, MD, Staff Member, Department of Neurological Sciences, Hospital Clínica Kennedy
ClinicalTrials.gov Identifier: NCT01627600     History of Changes
Other Study ID Numbers: TAP-001-2012
Study First Received: June 15, 2012
Last Updated: October 2, 2012
Health Authority: Ecuador: Ethical Committee

Keywords provided by Hospital Clínica Kennedy:
stroke
myocardial infarction
cardiovascular health
population study

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Heart Diseases
Ischemia
Stroke
Cerebral Infarction
Coronary Disease
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on August 28, 2014