Ignite Creation Date:
2024-05-06 @ 12:40 AM
Last Modification Date:
2024-10-26 @ 10:53 AM
Study NCT ID:
NCT01627600
Status:
COMPLETED
Last Update Posted:
2012-10-03
First Post:
2012-06-15
Brief Title:
Door-to-door Survey of Cardiovascular Health Stroke and Ischemic Heart Disease in Atahualpa
Sponsor:
Hospital Clínica Kennedy
Organization:
Hospital Clínica Kennedy
Study Overview
Official Title:
The Atahualpa Project a 3-phase Epidemiologic Survey
Status:
COMPLETED
Status Verified Date:
2012-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TAP
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None