Stroke Clinical Trial
Official title:
Matão Preventing Stroke (MaPS): Stroke Register in City of Matão, Brazil
Stroke is one of the most important cause of mortality and disability in Brazil. The city of
Matão, located in São Paulo state, with a population around 80.000 inhabitants, has
conditions to develop a community-based stroke study, which can answer important questions
regarding epidemiological data over the time.
Therefore, the purpose of this prospective community based study is to observe trends in
stroke incidence, types and sub-types of stroke, risk factors, prognosis, 30 days and one
year case-fatality during a follow-up of ten years.
This study offers the opportunity to conduct an epidemiological study of high quality which
can obtain data to formulate public politics to reduce the social and economic impact of
stroke in Brazil.
Introduction
Community-based stroke studies can answer important questions regarding incidence, case
fatality, recurrence, disability, assessment of risk factors and quality of stroke services.
Brazil had the highest age-adjusted stroke death rate of all Latin-American countries and the
risk of premature death due to stroke is one of the highest in the world. Although, a decline
in Brazilian stroke incidence and mortality has been observed in last years, stroke still has
an important social burden in the country.
The purpose of this study is to observe trends in stroke incidence, types and sub-types of
stroke, risk factors, prognosis, 30 days and one case-fatality during a follow-up of ten
years.
Objectives
The objectives of this project is to analyze:
The incidence of first-ever-in-a-lifetime stroke and incidence of pathological types,
subtypes, and rare causes Case fatalities Prognosis Early and long-term case-fatality rates
Poststroke morbidity Disability and handicap pos-stroke Risk factors Complications after
stroke Recurrent stroke Other vascular events Trends in stroke incidence
Subjects and Methods
Study Design A prospective population-based study is being performed since August, 1, 2015
Site of Investigation
Matão is a city located in São Paulo state, in the Brazilian southwest, 300 km northwest of
the state capital. Matão population was 78.690 in 2015 and estimated population in 2025 is
80791 inhabitants. There is only 1 hospital in the city, which serves the whole city and 2
other small towns. This is a general secondary level public hospital, with 190 beds,
including 18 beds in the intensive care unit and a radiology service with CT scan, the only
one in the city. The emergency department attends to 5000 to 6000 people monthly; including
emergency and urgency cases. The emergency department and intensive care unit take care of
acute stroke patients according to a written protocol that includes hospitalization and a
brain CT scan applied as soon as possible to all patients with suspected stroke.
Case Ascertainment All the physicians in the city are instructed to refer suspected acute
stroke patients to the research team or to the hospital emergency department. The
neurologists of the research team check all radiology records in suspected cases of stroke.
The hospital admission and discharge lists are checked weekly, searching for any suspected
case. All death certificates from the study period are checked monthly to search for stroke
patients who died in their homes and are not been referred to the hospital.
Inclusion criteria All suspected stroke patients living in Matão at an address belonging to
the city are included, regardless of age. The stroke criteria is rapidly developing clinical
symptoms and/or signs of focal and at time global loss of cerebral function, with symptoms
lasting more than 24 hours or leading to death, with no apparent cause other than that of
vascular origin. Only the first-ever-in-a-lifetime stroke is being included in the analysis.
Exclusion criteria Patients not living in Matão, who did not fulfill the clinical criteria
for stroke, with CT scan findings incompatible with a clinical suspicion of stroke and with
clinical evidence of a previous stroke event.
Follow-Up All included cases are being followed-up prospectively by the research team during
the first, third, sixth, months and 1 year after the stroke event with hospital visits.
Patients unable to attend the scheduled visits or who had moved to another city are being
contacted by telephone.
Classifications and Definitions The subtypes of stroke are being classified as ischemic
stroke and intracerebral hemorrhage on the basis of CT scan findings and subarachnoid
hemorrhage on the basis of CT scan and cerebrospinal fluid findings. Ischemic stroke is
subdivided into four subtypes according to the Oxfordshire Community Stroke Project
classification. For prognosis, is considered independence in activities of daily living if
patient reaches 100 points on the Barthel scale, independent gait if the patient reached 15
points in the mobility subsection of the Barthel scale, recurrent stroke if any new episode
of focal cerebral dysfunction persisting 24 hours during the follow-up period.
Data Analysis The age- and sex-specific annual incidence of first-ever-stroke per 100 000
inhabitants it is being estimated according to the official system of the Brazilian Ministry
of Health stratification and is presented as 10-year age bands as follows: younger than 45,
45 to 54, 55 to 64, 65 to 74, and 75 years or older. The incidence rate will be calculated as
the number of cases divided by the population at risk in the specific age bands, according
the respective year population. Inferential analyses will be performed by the 2-sided Fischer
exact test, with the level of significance set at 5%.
Discussion
Population-based studies can identify all types and sub-types of stroke in a community.
Studies including just data from hospitals, may not include mild stroke that are not
hospitalized and also severe stroke that die at home and do not have hospitals admission.
Additionally, it is fundamental that this studies should be prospective and in a long
follow-up. As diagnostic of stroke is basically clinical, prospective studies allow more
specific methods to define the type of stroke, risk factors, impairments and handicaps over
time.
The paucity of data regarding incidence on long follow-up and the distinct etiologies as
cause of stroke are being responsible as the main causes of the high incidence and case
fatality in the world. This study in Matão offers the opportunity to conduct an epidemiologic
study of high quality, which will be able to obtain data to formulate public politics to
reduce the social and economic impact of stroke in Brazil.
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