Ignite Creation Date:
2025-12-24 @ 4:59 PM
Ignite Modification Date:
2025-12-27 @ 7:38 PM
Study NCT ID:
NCT05256550
Status:
COMPLETED
Last Update Posted:
2023-08-25
First Post:
2022-02-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Stroke Outcome Analysis and Registry in Trinidad and Tobago
Sponsor:
Naveen Seecheran
Organization:
Study Overview
Official Title:
Stroke Outcome Analysis and Registry in Trinidad and Tobago; the StART Study
Status:
COMPLETED
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
StART
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: