Door-to-door Survey of Cardiovascular Health, Stroke and Ischemic Heart Disease in Atahualpa (TAP)
|ClinicalTrials.gov Identifier: NCT01627600|
Recruitment Status : Completed
First Posted : June 26, 2012
Last Update Posted : October 3, 2012
|Condition or disease||Phase|
|Stroke Ischemic Heart Disease||Phase 1|
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 . 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 .
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 :||Observational|
|Actual Enrollment :||642 participants|
|Observational Model:||Ecologic or Community|
|Official Title:||The Atahualpa Project, a 3-phase Epidemiologic Survey|
|Study Start Date :||June 2012|
|Primary Completion Date :||October 2012|
|Study Completion Date :||October 2012|
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.
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01627600
|Atahualpa, Santa Elena, Ecuador, 00000|
|Atahualpa, Santa Elena, Ecuador, 0901|
|Principal Investigator:||Oscar H Del Brutto, MD||Hospital Clinica Kennedy|