Stroke Outcome Analysis and Registry in Trinidad and Tobago

NCT05256550 | Completed

• 1 other identifier: CREC-SA.1394/02/2022
• Study Type: observational
• Target: 1,320
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Stroke

Keywords

stroke; mortality; functional outcome; risk factors; cerebrovascular disease

Outcome Measures

Primary Outcomes (2)

• 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

  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

  3 months after hospital admission

Secondary Outcomes (3)

• Incidence of persons admitted to hospital with stroke or transient ischemic attack

  At time of enrollment

• Number of males as compared to females admitted to hospital with cerebrovascular disease in Trinidad and Tobago

  At time of enrollment

• Identification of the age group that stroke and transient ischemic attack most commonly occur

  At time of enrollment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• Patients who are initially presumed as stroke due to neurological deficits or symptoms but have an alternative diagnosis on Computerized Tomography (CT) imaging.

Sponsors & Collaborators

• Naveen Seecheran: lead

Study Sites (1)

University of the West Indies

Saint Augustine, Trinidad and Tobago

Location

Related Publications (4)

• 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.

  PMID: 24081961 BACKGROUND

• Heuschmann 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.

  PMID: 21148118 BACKGROUND

• Sennfalt 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.

  PMID: 30580719 BACKGROUND

• Mahabir 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.

  PMID: 9924505 BACKGROUND

MeSH Terms

Conditions

Stroke; Cerebrovascular Disorders

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Naveen A Seecheran, MBBS MD MSc

  University of the West Indies

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: American Board of Internal Medicine (ABIM) certified Intervention Cardiologist; Lecturer (Crossed the Merit Bar) at University of the West Indies; Honorary Consultant and Clinical Lead of the Cardiac Care Unit, Eric Williams Medical Sciences Complex

Study Record Dates

• First Submitted: February 15, 2022
• First Posted: February 25, 2022
• Study Start: March 1, 2022
• Primary Completion: July 1, 2023
• Study Completion: August 1, 2023
• Last Updated: August 25, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

TR (1)