NCT03391102

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
840

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

December 22, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 5, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
7.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2025

Completed
Last Updated

January 5, 2018

Status Verified

December 1, 2017

Enrollment Period

2.9 years

First QC Date

December 22, 2017

Last Update Submit

December 29, 2017

Conditions

Stroke

Keywords

EpidemiologyCommunity-based study

Outcome Measures

Primary Outcomes (1)

  • Annual incidence of first-ever-stroke per 100 000 inhabitants

    Number of first-ever stroke divided by the population at risk.

    1 year

Interventions

Observational studyOTHER

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Carlos Fernando Malzoni

Matão, São Paulo, 15990180, Brazil

RECRUITING

Related Publications (4)

  • 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.

    PMID: 8610328RESULT

  • Ribeiro 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.

    PMID: 26811272RESULT

  • Cabral 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.

    PMID: 27064414RESULT

  • Bamford 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.

    PMID: 3266234RESULT

Related Links

MeSH Terms

Conditions

Stroke

Interventions

Observation

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Cesar Minelli, PhD,

    Hospital Carlos Fernando Malzoni

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Cewsar Minelli, PhD, MD

CONTACT

+55-16-33823388cdminelli@yahoo.com.br

Lucileni A Borin, Ps

CONTACT

+55-16-33832527lucileni.borin@hopitalmatao.com.br

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2017

First Posted

January 5, 2018

Study Start

August 1, 2015

Primary Completion

July 1, 2018

Study Completion

July 31, 2025

Last Updated

January 5, 2018

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will share

Data regarding demography and prognosis can be shared with other researchers.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
Data will become avaliable on July, 2018
Access Criteria
Researches interested in stroke epidemiology

Locations

BR(1)