StrokeStARTNCT05256550
Stroke Outcome Analysis and Registry in Trinidad and Tobago
An observational study of Stroke, run by Naveen Seecheran at 1 site in Trinidad and Tobago.
Trial summary
This is a prospective observational study to assess risk factors, functional outcomes and mortality at three months for persons admitted to hospital with stroke and transient ischemic attack. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- How many people
- 1,320 participants
- Where
- 1 siteTrinidad and Tobago
- Study dates
- 1 Mar 2022to 1 Aug 2023
- How long will I take part?
- 3 Months
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will be selected from a hospital in Trinidad and Tobago, the Eric Williams medical sciences complex. Persons with a neurological deficit and corresponding Computerized Tomography (CT) imaging that confirms the diagnosis of stroke or transient ischemic attack will be recruited into the study.
Who may be able to join
- more than 18 years of age
- have a neurological deficit with Computerized Tomography (CT) imaging confirming the diagnosis of a stroke (including both ischemic, hemorrhagic, and subarachnoid hemorrhage) and transient ischemic attack.
- Participant or relative must be accessible via telephone for 3 month follow up.
Who cannot join
- Patients who are initially presumed as stroke due to neurological deficits or symptoms but have an alternative diagnosis on Computerized Tomography (CT) imaging.
Trial locations and contacts
1 site in 1 country.
Trinidad and Tobago1 site
University of the West Indies
Saint Augustine
About this study
Official title: Stroke Outcome Analysis and Registry in Trinidad and Tobago; the StART Study
This is a prospective observational study to assess risk factors, functional outcomes and mortality at three months for persons admitted to hospital with stroke and transient ischemic attack. Persons who were admitted with a diagnosis of stroke or transient ischemic attack at Eric Williams Medical Sciences Complex (EWMSC), Trinidad and Tobago will be screened for eligibility as participants. Demographic and clinical data will be taken from the patient records and then a follow up survey regarding functional outcome will be done at three months. Informed verbal consent will be obtained. Data will be stored in case report forms, and unique coded identifiers will be used to preserve participant anonymity. Data will also be encrypted and kept in a password protected computer in a locked cabinet. Two clinical research associates will check quality of data throughout the study and routine statistical analysis will be performed.
Read the detailed description
This is a prospective observational study. Persons admitted with a diagnosis of stroke or transient ischemic attack at Eric Williams Medical Sciences Complex, Trinidad and Tobago will be screened for eligibility.
Persons with a neurological deficit and corresponding computerized tomography (CT) imaging that confirms the diagnosis of stroke or transient ischemic attack will be recruited into the study. Demographic and clinical data will be collected from the participant's medical file and entered into a case report form. Each participant will have a unique code to provide anonymity. At three months following the admission date, the participant or relative will be contacted via telephone The participant's functional outcome will be assessed via this telephone interview and data entered into the case report form as a score on the modified rankin scale.
Verbal consent will be obtained over the phone in the presence of two witnesses, one on the end of the participant and another on the end of the investigator. The investigator will sign the consent form to confirm verbal consent was given on behalf of the participant, only after a discussion regarding the study, its methods, risks, benefits, confidentiality and informing the participant of their right to withdraw at any point. The two witnesses will also be recorded.
Data will be coded per participant by first letter of first name, first letter of last name followed by numerical date of birth in the order day, month and year in a password protected and encrypted database program in the double-locked office of investigator, Dr. Naveen Seecheran at the Department of Clinical Medicine office, 2nd Floor, Building 34, Eric Williams Medical Sciences Complex. Each case report form and study database will be reviewed by two clinical research associates to minimize error, clean and reconcile any conflicting data.
One thousand, three hundred and twenty persons will be approached for enrolment of this study with an aim of data from 1053 participants being entered into this study, catering for loss to follow up and calculated using power 90 percent and minimal detectable difference 10 percent. The probability is 90 percent that the study will detect a relationship between the independent and dependent variables at a two sided 0.05 significance level, if the true change in the dependent variable is 0.100 standard deviations per one standard deviation chance in the independent variable. Cases with missing or unreported data will not be enrolled in this study.
The study biostatistician will perform routine statistical analyses with SPSS v. 24.0 software (SPSS, Chicago, IL). Continuous variables are expressed as means ± standard deviation. Categorical variables are to be expressed as frequencies and percentages. Student's t test will be used to compare continuous variables. Comparisons between categorical variables will be performed using two-tailed Fisher's exact test or the Pearson's χ2 test, as appropriate. A p value of < 0.05 will be considered statistically significant. No adjustments for multiple comparisons will be made. Results will be reported as least-square mean ± Standard Error of the Mean for the detailed analyses.
- Conditions
- Stroke
- Keywords
- stroke, mortality, functional outcome, risk factors, cerebrovascular disease
- Medical subject headings
- Stroke, Cerebrovascular Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of risk factors in persons admitted to hospital with cerebrovascular disease in Trinidad and Tobago
Identification of most common risk factors among persons admitted to hospital with strokes and transient ischemic attacks in Trinidad and Tobago
Measured: At time of enrollment
Mortality rate at 3 months as assessed by number of participant deaths within 3 months of hospital admission
Number of participant deaths within three months of hospital admission
Measured: 3 months after hospital admission
Secondary outcomes (3)
Incidence of persons admitted to hospital with stroke or transient ischemic attack
Number of persons admitted to hospital with ischemic stroke, hemorrhagic stroke or transient ischemic attack
Measured: At time of enrollment
Number of males as compared to females admitted to hospital with cerebrovascular disease in Trinidad and Tobago
Number of males as compared to females admitted to hospital with ischemic stroke, hemorrhagic stroke and transient ischemic attack
Measured: At time of enrollment
Identification of the age group that stroke and transient ischemic attack most commonly occur
Identification of the age groups in which ischemic stroke, hemorrhagic stroke and transient ischemic attacks most commonly occur among participants
Measured: At time of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2022
- Study start1 Mar 2022
- Primary completion1 Jul 2023
- Study completion1 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- Other
- Time perspective
- Prospective
- Enrolment
- 1,320 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Naveen Seecheran
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Naveen Seecheran, The University of The West Indies
- Investigators
- Naveen A Seecheran, MBBS MD MSc, Principal investigator, University of the West Indies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05256550
- Sponsor's protocol ID
- CREC-SA.1394/02/2022
- Acronym
- StART
- Status last verified
- Aug 2023
- First submitted
- 15 Feb 2022
- Last updated
- 25 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tanne D, Koton S, Bornstein NM. National stroke registries: what can we learn from them? Neurology. 2013 Oct 1;81(14):1257-9. doi: 10.1212/WNL.0b013e3182a6ca52. No abstract available.
PubMed 24081961Heuschmann PU, Wiedmann S, Wellwood I, Rudd A, Di Carlo A, Bejot Y, Ryglewicz D, Rastenyte D, Wolfe CD; European Registers of Stroke. Three-month stroke outcome: the European Registers of Stroke (EROS) investigators. Neurology. 2011 Jan 11;76(2):159-65. doi: 10.1212/WNL.0b013e318206ca1e. Epub 2010 Dec 9.
PubMed 21148118Sennfalt S, Norrving B, Petersson J, Ullberg T. Long-Term Survival and Function After Stroke: A Longitudinal Observational Study From the Swedish Stroke Register. Stroke. 2019 Jan;50(1):53-61. doi: 10.1161/STROKEAHA.118.022913. Epub 2018 Dec 7.
PubMed 30580719Mahabir D, Bickram L, Gulliford MC. Stroke in Trinidad and Tobago: burden of illness and risk factors. Rev Panam Salud Publica. 1998 Oct;4(4):233-7. doi: 10.1590/s1020-49891998001000002.
PubMed 9924505Seecheran NA, Maharaj N, Swarath S, Maharajh A, Gowrie-Sankar S, Charles R, Lobin R, Richard S, Battersby S, Rohit K, Nanan S, Rohit K, Maharaj R, Lalla A, Juman Z, Thackoorcharan S, Bissram S, Frederick JM, Ramcharan P, Seecheran V, Seecheran R, Peram L, Motilal S, Giddings S, Sandy S, Ramlackhansingh A, Maraj N, Panday A. Stroke risk factors and outcomes in Trinidad and Tobago: the START study. BMC Neurol. 2026 Jun 12. doi: 10.1186/s12883-026-05063-5. Online ahead of print.
PubMed 42277678
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stroke Outcome Analysis and Registry in Trinidad and Tobago; the StART Study
- ClinicalTrials.gov ID
- NCT05256550
- Acronym / sponsor ID
- StART / CREC-SA.1394/02/2022
- Conditions
- Stroke
- Keywords
- stroke, mortality, functional outcome, risk factors, cerebrovascular disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,320 participants (actual)
- Lead sponsor
- Naveen SeecheranUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 25 Feb 2022 (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.
This is a prospective observational study to assess risk factors, functional outcomes and mortality at three months for persons admitted to hospital with stroke and transient ischemic attack. Persons who were admitted with a diagnosis of stroke or transient ischemic attack at Eric Williams Medical Sciences Complex (EWMSC), Trinidad and Tobago will be screened for eligibility as participants. Demographic and clinical data will be taken from the patient records and then a follow up survey regarding functional outcome will be done at three months. Informed verbal consent will be obtained. Data will be stored in case report forms, and unique coded identifiers will be used to preserve participant anonymity. Data will also be encrypted and kept in a password protected computer in a locked cabinet. Two clinical research associates will check quality of data throughout the study and routine statistical analysis will be performed.
Detailed description
This is a prospective observational study. Persons admitted with a diagnosis of stroke or transient ischemic attack at Eric Williams Medical Sciences Complex, Trinidad and Tobago will be screened for eligibility.
Persons with a neurological deficit and corresponding computerized tomography (CT) imaging that confirms the diagnosis of stroke or transient ischemic attack will be recruited into the study. Demographic and clinical data will be collected from the participant's medical file and entered into a case report form. Each participant will have a unique code to provide anonymity. At three months following the admission date, the participant or relative will be contacted via telephone The participant's functional outcome will be assessed via this telephone interview and data entered into the case report form as a score on the modified rankin scale.
Verbal consent will be obtained over the phone in the presence of two witnesses, one on the end of the participant and another on the end of the investigator. The investigator will sign the consent form to confirm verbal consent was given on behalf of the participant, only after a discussion regarding the study, its methods, risks, benefits, confidentiality and informing the participant of their right to withdraw at any point. The two witnesses will also be recorded.
Data will be coded per participant by first letter of first name, first letter of last name followed by numerical date of birth in the order day, month and year in a password protected and encrypted database program in the double-locked office of investigator, Dr. Naveen Seecheran at the Department of Clinical Medicine office, 2nd Floor, Building 34, Eric Williams Medical Sciences Complex. Each case report form and study database will be reviewed by two clinical research associates to minimize error, clean and reconcile any conflicting data.
One thousand, three hundred and twenty persons will be approached for enrolment of this study with an aim of data from 1053 participants being entered into this study, catering for loss to follow up and calculated using power 90 percent and minimal detectable difference 10 percent. The probability is 90 percent that the study will detect a relationship between the independent and dependent variables at a two sided 0.05 significance level, if the true change in the dependent variable is 0.100 standard deviations per one standard deviation chance in the independent variable. Cases with missing or unreported data will not be enrolled in this study.
The study biostatistician will perform routine statistical analyses with SPSS v. 24.0 software (SPSS, Chicago, IL). Continuous variables are expressed as means ± standard deviation. Categorical variables are to be expressed as frequencies and percentages. Student's t test will be used to compare continuous variables. Comparisons between categorical variables will be performed using two-tailed Fisher's exact test or the Pearson's χ2 test, as appropriate. A p value of < 0.05 will be considered statistically significant. No adjustments for multiple comparisons will be made. Results will be reported as least-square mean ± Standard Error of the Mean for the detailed analyses.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will be selected from a hospital in Trinidad and Tobago, the Eric Williams medical sciences complex. Persons with a neurological deficit and corresponding Computerized Tomography (CT) imaging that confirms the diagnosis of stroke or transient ischemic attack will be recruited into the study.
Key inclusion criteria (3 listed)
- more than 18 years of age
- have a neurological deficit with Computerized Tomography (CT) imaging confirming the diagnosis of a stroke (including both ischemic, hemorrhagic, and subarachnoid hemorrhage) and transient ischemic attack.
- Participant or relative must be accessible via telephone for 3 month follow up.
Key exclusion criteria (1 listed)
- Patients who are initially presumed as stroke due to neurological deficits or symptoms but have an alternative diagnosis on Computerized Tomography (CT) imaging.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
prevalence of risk factors in persons admitted to hospital with cerebrovascular disease in Trinidad and Tobago
Time frame: At time of enrollment
Identification of most common risk factors among persons admitted to hospital with strokes and transient ischemic attacks in Trinidad and Tobago
Mortality rate at 3 months as assessed by number of participant deaths within 3 months of hospital admission
Time frame: 3 months after hospital admission
Number of participant deaths within three months of hospital admission
3 secondary outcomes
Incidence of persons admitted to hospital with stroke or transient ischemic attack
Time frame: At time of enrollment
Number of males as compared to females admitted to hospital with cerebrovascular disease in Trinidad and Tobago
Time frame: At time of enrollment
Identification of the age group that stroke and transient ischemic attack most commonly occur
Time frame: At time of enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2023.
- Background: PubMed 24081961Tanne D, Koton S, Bornstein NM. National stroke registries: what can we learn from them? Neurology. 2013 Oct 1;81(14):1257-9. doi: 10.1212/WNL.0b013e3182a6ca52. No abstract available.
- Background: PubMed 21148118Heuschmann PU, Wiedmann S, Wellwood I, Rudd A, Di Carlo A, Bejot Y, Ryglewicz D, Rastenyte D, Wolfe CD; European Registers of Stroke. Three-month stroke outcome: the European Registers of Stroke (EROS) investigators. Neurology. 2011 Jan 11;76(2):159-65. doi: 10.1212/WNL.0b013e318206ca1e. Epub 2010 Dec 9.
- Background: PubMed 30580719Sennfalt S, Norrving B, Petersson J, Ullberg T. Long-Term Survival and Function After Stroke: A Longitudinal Observational Study From the Swedish Stroke Register. Stroke. 2019 Jan;50(1):53-61. doi: 10.1161/STROKEAHA.118.022913. Epub 2018 Dec 7.
- Background: PubMed 9924505Mahabir D, Bickram L, Gulliford MC. Stroke in Trinidad and Tobago: burden of illness and risk factors. Rev Panam Salud Publica. 1998 Oct;4(4):233-7. doi: 10.1590/s1020-49891998001000002.
- Derived from this study: PubMed 42277678Seecheran NA, Maharaj N, Swarath S, Maharajh A, Gowrie-Sankar S, Charles R, Lobin R, Richard S, Battersby S, Rohit K, Nanan S, Rohit K, Maharaj R, Lalla A, Juman Z, Thackoorcharan S, Bissram S, Frederick JM, Ramcharan P, Seecheran V, Seecheran R, Peram L, Motilal S, Giddings S, Sandy S, Ramlackhansingh A, Maraj N, Panday A. Stroke risk factors and outcomes in Trinidad and Tobago: the START study. BMC Neurol. 2026 Jun 12. doi: 10.1186/s12883-026-05063-5. Online ahead of print.
- Individual participant dataSharing planned: No
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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.
Naveen A Seecheran, MBBS MD MSc principal investigator
University of the West Indies
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 Naveen Seecheran at 1 site in Trinidad and Tobago.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2023. 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 Trinidad and Tobago. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevalence of risk factors in persons admitted to hospital with cerebrovascular disease in Trinidad and Tobago (time frame: At time of enrollment). The study lists 2 primary outcomes in all. 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 NCT05256550, which also lists 5 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 25 Aug 2023.