StrokeMaPSNCT03391102
Matão Preventing Stroke (MaPS): a Stroke Register Study
An observational study of Stroke, run by Centro Neurológico de Pesquisa e Reabiitação, Brazil at 1 site in Brazil.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stroke
- What is being tested?
- Observational study
- How many people
- 840 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2015to 31 Jul 2025
- How long will I take part?
- 10 Years
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population belongs to Matão, Brazil, São Paulo state, located 300 km northwest of the state capital. The number od inhabitants in 2014 was estimated in 78.910 and in 2025, 80.791 habitants, with no difference in sex distribution. The economy is mainly based on agricultural and industrial activities and on general services. Ethnicity is diverse, but most people are of white ethnicity, descendants of European immigrants. The population is urban and stable, with a low rate of interurban migration. Approximately 95% of all dwellings have piped water, a sewage network, and electricity.
Inclusion Criteria: All suspected stroke patients living in Matão at an address belonging to the city were included, regardless of age. The stroke criteria were those defined by the Word Health Organization: "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" 12 Although every stroke was recorded, only the first-ever-in-a-lifetime stroke was included in the analysis.
Exclusion Criteria: Patients not living in Matão, who did not fulfill the clinical criteria for stroke, with CT or RMI scan findings incompatible with a clinical suspicion of stroke, and with clinical evidence of a previous stroke event.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Hospital Carlos Fernando Malzoni
Matão, São Paulo, 15990180
Cesar Minelli, PhD, MD, +55- 1633823388, cdminelli@yahoo.com.br
About this study
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.
Read the detailed description
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.
- Conditions
- Stroke
- Being tested
- Observational study
- Keywords
- Epidemiology, Community-based study
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational studyOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Annual incidence of first-ever-stroke per 100 000 inhabitants
Number of first-ever stroke divided by the population at risk.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2018
- Study startAug 2015
- Primary completionJul 2018 (estimated)
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- Prospective
- Enrolment
- 840 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Centro Neurológico de Pesquisa e Reabiitação, Brazil
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cesar Minelli, PhD,, Principal investigator, Hospital Carlos Fernando Malzoni
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03391102
- Sponsor's protocol ID
- Cenp-Reab
- Acronym
- MaPS
- Status last verified
- Dec 2017
- First submitted
- 22 Dec 2017
- Last updated
- 5 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data regarding demography and prognosis can be shared with other researchers.
Publications
Sudlow CL, Warlow CP. Comparing stroke incidence worldwide: what makes studies comparable? Stroke. 1996 Mar;27(3):550-8. doi: 10.1161/01.str.27.3.550.
PubMed 8610328Ribeiro AL, Duncan BB, Brant LC, Lotufo PA, Mill JG, Barreto SM. Cardiovascular Health in Brazil: Trends and Perspectives. Circulation. 2016 Jan 26;133(4):422-33. doi: 10.1161/CIRCULATIONAHA.114.008727.
PubMed 26811272Cabral NL, Cougo-Pinto PT, Magalhaes PS, Longo AL, Moro CH, Amaral CH, Costa G, Reis FI, Goncalves AR, Nagel V, Pontes-Neto OM. Trends of Stroke Incidence from 1995 to 2013 in Joinville, Brazil. Neuroepidemiology. 2016;46(4):273-81. doi: 10.1159/000445060. Epub 2016 Apr 12.
PubMed 27064414Bamford J, Sandercock P, Dennis M, Warlow C, Jones L, McPherson K, Vessey M, Fowler G, Molyneux A, Hughes T, et al. A prospective study of acute cerebrovascular disease in the community: the Oxfordshire Community Stroke Project 1981-86. 1. Methodology, demography and incident cases of first-ever stroke. J Neurol Neurosurg Psychiatry. 1988 Nov;51(11):1373-80. doi: 10.1136/jnnp.51.11.1373.
PubMed 3266234
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Matão Preventing Stroke (MaPS): Stroke Register in City of Matão, Brazil
- ClinicalTrials.gov ID
- NCT03391102
- Acronym / sponsor ID
- MaPS / Cenp-Reab
- Conditions
- Stroke
- Keywords
- Epidemiology, Community-based study
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 840 participants (estimated)
- Lead sponsor
- Centro Neurológico de Pesquisa e Reabiitação, BrazilUniversity, hospital or other
- Study start
- Aug 2015 (actual)
- Primary completion
- Jul 2018 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 5 Jan 2018 (actual)
- 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.
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.
Detailed description
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population belongs to Matão, Brazil, São Paulo state, located 300 km northwest of the state capital. The number od inhabitants in 2014 was estimated in 78.910 and in 2025, 80.791 habitants, with no difference in sex distribution. The economy is mainly based on agricultural and industrial activities and on general services. Ethnicity is diverse, but most people are of white ethnicity, descendants of European immigrants. The population is urban and stable, with a low rate of interurban migration. Approximately 95% of all dwellings have piped water, a sewage network, and electricity.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational study | Other | – |
Primary outcome
Annual incidence of first-ever-stroke per 100 000 inhabitants
Time frame: 1 year
Number of first-ever stroke divided by the population at risk.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2018.
- Results publication: PubMed 8610328Sudlow CL, Warlow CP. Comparing stroke incidence worldwide: what makes studies comparable? Stroke. 1996 Mar;27(3):550-8. doi: 10.1161/01.str.27.3.550.
- Results publication: PubMed 26811272Ribeiro AL, Duncan BB, Brant LC, Lotufo PA, Mill JG, Barreto SM. Cardiovascular Health in Brazil: Trends and Perspectives. Circulation. 2016 Jan 26;133(4):422-33. doi: 10.1161/CIRCULATIONAHA.114.008727.
- Results publication: PubMed 27064414Cabral NL, Cougo-Pinto PT, Magalhaes PS, Longo AL, Moro CH, Amaral CH, Costa G, Reis FI, Goncalves AR, Nagel V, Pontes-Neto OM. Trends of Stroke Incidence from 1995 to 2013 in Joinville, Brazil. Neuroepidemiology. 2016;46(4):273-81. doi: 10.1159/000445060. Epub 2016 Apr 12.
- Results publication: PubMed 3266234Bamford J, Sandercock P, Dennis M, Warlow C, Jones L, McPherson K, Vessey M, Fowler G, Molyneux A, Hughes T, et al. A prospective study of acute cerebrovascular disease in the community: the Oxfordshire Community Stroke Project 1981-86. 1. Methodology, demography and incident cases of first-ever stroke. J Neurol Neurosurg Psychiatry. 1988 Nov;51(11):1373-80. doi: 10.1136/jnnp.51.11.1373.
- population stratification by age bandsLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Data regarding demography and prognosis can be shared with other researchers.
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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.
Cesar Minelli, PhD, principal investigator
Hospital Carlos Fernando Malzoni
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Centro Neurológico de Pesquisa e Reabiitação, Brazil at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cewsar Minelli, PhD, MD (+55-16-33823388, cdminelli@yahoo.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Annual incidence of first-ever-stroke per 100 000 inhabitants (time frame: 1 year). 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 NCT03391102, which also lists 4 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 5 Jan 2018.